United States Patent: (10) Patent No .: US 9, 956, 405 B2 (45) Date of Patent: May 1, 2018

THIONVIULUI DAT HITTATURALE DI TALK
US009956405B2
(12) United States Patent ( 10) Patent No.: US 9, 956 ,405 B2

Goldwasser et al. (45) Date of Patent: May 1, 2018
(54 ) TRANSDERMAL ELECTRICAL ( 56 ) References Cited
STIMULATION AT THE NECK TO INDUCE
NEUROMODULATION U . S . PATENT DOCUMENTS
(71) Applicant: Thync Global, Inc ., Los Gatos, CA 3 ,255 ,753 A 6 / 1966 Wing
(US ) 3,620 ,219 A 11/ 1971 Barker
(Continued )
(72 ) Inventors : Isy Goldwasser , Los Gatos, CA (US );
Douglas Jeffery , San Jose , CA (US ); FOREIGN PATENT DOCUMENTS
Sumon K . Pal, Boston , MA (US ); EP 502919 B1 11/1993
Wing Law , Cupertino , CA (US ) EP 801957 Al 10 / 1997
( 73 ) Assignee : Thyne Global, Inc., Los Gatos , CA (Continued )
(US) OTHER PUBLICATIONS
( * ) Notice : Subject to any disclaimer, the term of this Aston - Jones et al., An integrative theory of locus coeruleus-norepi
patent is extended or adjusted under 35 nephrine function : adaptive gain and optimal performance; Annu .
U . S .C . 154 (b ) by 0 days . days . Rev. Neurosci.; 28 : pp . 403 -450 ; Jul. 21, 2005.
(21) Appl. No.: 15 /601,394 (Continued )
( 22 ) Filed : May 22 , 2017 Primary Examiner — Carl H Layno
Prior Publication Data Assistant Examiner - Erin M Piateski
(65) (74 ) Attorney, Agent, or Firm — Shay Glenn LLP
US 2017/0252562 A1 Sep. 7, 2017 (57) ABSTRACT
Related U .S . Application Data
(60 ) Provisional application No.62/ 431 ,365, filed on Dec . Described herein are methods and apparatuses for the appli
7 , 2016 . cation of transdermal electrical stimulation ( TES) in order to
modulate a user ' s cognitive state to induce a state of calm or
(51 ) Int. Cl. relaxation . The apparatuses described herein include neck
A61N 1/ 36 ( 2006 .01) worn devices having electrodes ( or configured to connect to
A6IN 1 /04 ( 2006 .01) electrodes, including automatically self - connecting to elec
trodes) adapted to couple to the midline of the back of user ' s
( Continued ) neck . A neck -worn controller may be configured as a cord ,
(52) CPC
U .S . CI.......... A61N 1/36025 (2013.01); A61M 21/ 02
band, wire , torc , necklace , loop , strap , or the like, and may
be rigid or semi-rigid and may be worn at least partially
( 2013 .01 ); A61N 1 /0456 ( 2013 .01); A6IN around the subject's neck . The controller may controllably
1 /0492 (2013 .01 ); A61M 2021 /0072 ( 2013 .01) apply one or more waveforms to the electrodes of the
(58) Field of Classification Search electrode pad (e . g ., patch ) to deliver TES adapted to induce
???. . ............. A61N 1 /36025 ; A61N 1 /0456 ; A61N or enhance a relaxed cognitive state .
1/0492 ; A61M 21 /02 ; A61M 2021/0072
(Continued ) 23 Claims, 47 Drawing Sheets
2505 -
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US 9 , 956 , 405 B2
Page 2
(51) Int. Cl. 9 ,014 ,811 B2 4 / 2015 Pal et al.

A61M 21/02 (2006 .01 ) 9 ,067,054 B26 / 2015 Simon et al.
A61M 21 / 00 ( 2006 . 01) 9 , 168, 374 B2 10 / 2015 Su
9,205, 258 B2 12/ 2015 Simon et al .
( 58 ) Field of Classification Search 9 , 233, 244 B2 1/2016 Pal et al.
USPC .......... 607/45 9 ,248,292 B2 2 /2016 Trier et al.
See application file for complete search history . 9 , 333 ,334
9 ,364,674
B2
B2
5 /2016
6 /2016
Jeffery et al.
Cook et al.
(56 ) References Cited 9 ,393,401 B2 7 / 2016 Goldwasser et al.
9 ,393, 430 B2 7 / 2016 Demers et al.
U . S . PATENT DOCUMENTS 9 ,399 ,126 B2 7 /2016 Pal et al.
9 , 415 ,219 B2 8 /2016 Simon et al .
9 , 440, 070 B2 9 /2016 Goldwasser et al .
3 ,648,708 A 3 / 1972 Haeri 9, 446, 242 B2 9 / 2016 Griffith
4 ,418 ,687 A 12 / 1983 Matsumoto et al. 9, 474, 891 B2 10 / 2016 Demers et al .
4 ,431,000 A 2 / 1984 Butler et al. 9 , 474, 905 B2 10 /2016 Doan et al.
4 ,646 , 744 A 3 / 1987 Capel 9 , 517,351 B2 12 /2016 Charlesworth et al.
4 ,664, 117 A 5 / 1987 Beck 9 , 656, 076 B2 5 / 2017 Trier et al.
5 , 144 ,952 A 9 / 1992 Frachet et al. 9 , 700, 725 B2 7 /2017 Zhu
5 , 183, 041 A 2 / 1993 Toriu et al. 9 , 731, 116 B2 8 / 2017 Chen
5 ,335,657 A 8 / 1994 Terry et al. 9 , 744, 347 B2 8 /2017 Chen et al.
5 ,342 ,410 A 8 / 1994 Braverman 9 , 764,133 B2 9 /2017 Thomas et al.
5 ,397 ,338 A 3 / 1995 Grey et al . 9 ,782 ,587 B2 . 10 /2017 Trier et al.
5 ,476 ,481 A 12 / 1995 Schondorf 2002/0116036 A1 8/2002 Daignault et al.
5 , 487 ,759 A 1/ 1996 Bastyr et al. 2003/0171685 A1 9 / 2003 Lesser et al.
5 , 514 , 175 A 5 / 1996 Kim et al. 2003 /0225323 Al 12 / 2003 Klani et al.
5 ,540 ,736 A 7 / 1996 Haimovich et al. 2004 /0098065 Al 5 /2004 Hagglof et al.
5 ,573 ,552 A 11/ 1996 Hansjurgens 2004/ 0267333 Al 12/2004 Kronberg
5 ,578, 065 A 11/ 1996 Hattori et al. 2005/0165460 A17 / 2005 Erfan
5 ,593,427 A 1/ 1997 Gliner et al. 2005/ 0267388 A1 12/2005 Hanna
5 ,738 ,647 A 4 / 1998 Bernhard et al. 2006 /0064139 Al 3 / 2006 Chung et al.
5 ,792, 067 A 8 / 1998 Karell 2006 /0149119 Al 7 /2006 Wang
6 ,066 , 163 A 5 / 2000 John 2006 /0206163 Al 9 / 2006 Wahlstrand et al.
6 ,280, 454 B1 8 / 2001 Wang 2007 /0088419 Al 4 /2007 Fiorina et al.
6 , 324, 432 B1 11/ 2001 Rigaux et al. 2007/0100275 Al 5 / 2007 Fischer et al.
6, 445,955 B1 9 / 2002 Michelson et al. 2007 /0173890 A1 7 /2007 Armstrong
6, 463 ,328 B1 10 / 2002 John 2007 / 0213790 A1 9 / 2007 Nolan et al.
6 , 526, 318 B1 2 / 2003 Ansarinia 2007/0276451 Al 11/2007 Rigaux
6 , 567 ,702 B1 5 / 2003 Nekhendzy et al. 2008/ 0045882 Al 2 /2008 Finsterwald
6 , 731, 987 B1 5 / 2004 McAdams et al. 2008 /0132974 A1 6 / 2008 Strother et al .
6 , 983, 184 B2 1/ 2006 Price 2008 /0208266 AL 8 /2008 Lesser et al.
7 , 120,499 B2 10 / 2006 Thrope et al. 2008/0215113 A1 * 9 /2008 Pawlowicz ....... A61N 1/ 36021
7 ,146,217 B2 12 / 2006 Firlik et al. 607/ 46
7 ,376,467 B2 5 / 2008 Thrope et al . 2008/ 0275293 AL 11/ 2008 Lattner et al.
7, 422,555 B2 9 /2008 Zabara 2008/0281368 A 11/2008 Bulkes et al.
7 ,577,481 B2 8/ 2009 Firlik et al. 2008/0319505 Al 12 /2008 Boyden et al
7 ,660 , 636 B2 2 /2010 Castel et al. 2009 /0048642 Al 2 /2009 Goroszeniuk
7 ,801 , 600 B1 9 / 2010 Carbunaru et al. 2009/ 0099623 A1 4 /2009 Bentwich
7 ,891, 615 B2 2 /2011 Bevirt 2009 /0112280 A1 4 /2009 Wingeier et al .
7 , 949, 403 B2 5 / 2011 Palermo et al. 2009 /0177243 A1 7 / 2009 Lebedev et al.
8,029, 431 B2 10 / 2011 Tononi 2009 /0210028 A1 8 /2009 Rigaux et al.
8, 086,318 B2 12 /2011 Strother et al. 2009 /0240303 A1 9 /2009 Wahlstrand et al.
8 ,097,926 B2 1/ 2012 De Graff et al. 2009 /0270947 Al 10 /2009 Stone et al.
8 ,121, 695 B2 2 / 2012 Gliner et al. 2009/ 0287108 Al 11/2009 Levy
8 , 150, 537 B2 4 / 2012 Tanaka et al. 2010 / 0057154 A1 3 / 2010 Dietrich et al.
8,190 , 248 B2 5 / 2012 Besio et al. 2010 /0145399 Al 6 / 2010 Johari et al.
8 , 197, 276 B2 6 / 2012 Egloff et al. 2010 /0152817 A1 6 /2010 Gillbe
8 ,204 , 601 B2 6 / 2012 Moyer et al. 2010 /0256436 A1 10 /2010 Partsch et al.
8,239, 030 B1 8 / 2012 Hagedorn et al. 2011/0029045 Al 2 /2011 Cevette et al .
8,265 , 761 B2 9 / 2012 Siever 2011/0082326 A1 4 / 2011 Mishelevich et al.
8,280 ,502 B2 10 / 2012 Hargrove et al. 2011/ 0082515 Al 4 / 2011 Libbus et al.
8 ,380,315 B2 2/ 2013 DeGiorgio et al. 2011/0093033 A1 4 / 2011 Nekhendzy
8 , 428, 738 B2 4 / 2013 Valencia 2011 /0112394 Al 5 /2011 Mishelevich
8,463 ,383 B2 6 / 2013 Sakai et al. 2011 /0112590 A1 5 /2011 Wu et al.
8 , 494, 625 B2 7 /2013 Hargrove 2011/0114191 A1 5 / 2011 Wheater et al.
8,494 , 627 B2 7 / 2013 Bikson et al . 2011/0137381 A1 6 / 2011 Lee et al.
8 ,506,469 B2 8 / 2013 Dietrich et al. 2011/0144716 Al 6 / 2011 Bikson et al.
8,532,758 B2 9 / 2013 Silverstone 2011 /0160811 A1 6 /2011 Walker
8, 560 ,075 B2 10 / 2013 Covalin 2011/0172752 A1
7/ 2011 Bingham et al.
8 , 571, 651 B2 10 /2013 Ben - Ezra et al. 2011 /0190846 A1
8 /2011 Ruffini et al.
8,583 ,256 B2 11/ 2013 Tracey et al. 2011/0230701 A1
9 / 2011 Simon et al.
8,612, 005 B2 12/ 2013 Rezai et al. 2011/0230702 A1
9 /2011 Honour
8 ,639,343 B2 1/ 2014 De Vos
8 , 660, 644 B2 2 /2014 Jaax et al. 2011/0230938 A1
9 /2011 Simon et al.
8,688, 239 B2 4 / 2014 Hartlep et al . 2011/ 0270345 A1 11/ 2011 Johnston et al.
8 , 843 ,210 B2 9 / 2014 Simon et al. 2011 /0276112 AL 11/ 2011 Simon et al.
8 , 874, 219 B2 10 / 2014 Trier et al . 2011 /0288610 AL 11/ 2011 Brocke
8, 903 ,494 B2 12 / 2014 Goldwasser et al. 2011/ 0319950 Al 12/ 2011 Sullivan
8 , 983 ,621 B23 /2015 Hou et al . 2012/ 0016431 AL 1/ 2012 Paul et al.
9 ,002, 458 B2 4 / 2015 Pal et al. 2012 /0029591 A12 / 2012 Simon et al.
US 9 , 956 ,405 B2
Page 3
( 56 ) References Cited WO
WO
WO2010 /067145
WO2011/ 147546
A1
Al
6 / 2010
12 /2011
U . S . PATENT DOCUMENTS WO WO2012 /082960 A2 6 /2012
wo WO2012/089588 A1 7 / 2012
2012/ 0029601 A1 2/ 2012 Simon et al. WO WO2012 / 116407 Al 9 /2012
2012 /0109251 A 5 / 2012 Lebedev et al. WO WO2012 / 129574 A2 9 /2012
2012 /0149973 Al 6 /2012 Holloway Wo WO2012 / 150600 A2 11/2012
2012 /0165759 Al 6 / 2012 Rogers et al. wo WO2012 / 156051 A111/ 2012
2012 /0185020 Al 7 / 2012 Simon et al. wo WO2012 / 156052 A2 11/ 2012
2012 / 0209346 A1 8/ 2012 Bikson et al. WO WO2013 /071307 Al 5 / 2013
2012 / 0245409 A1 9 / 2012 Liang WO WO2013/ 192582 A112 /2013
2012 /0245653 A1 9 / 2012 Bikson et al . WO WO2014 / 107624 AL 7 /2014
2012 /0302912 Al 11 / 2012 Moffitt et al. wo WO2015 /061663 A14 / 2015
2013 /0035734 Al 2 /2013 Soler et al . WO WO2015 / 143053 AL 9 /2015
2013/0041235 Al 2 / 2013 Rogers et al. WO WO2015 / 183690 Al 12 / 2015
2013 /0060304 A1 3 /2013 La Tendresse et al.
2013 /0066395 A1 3 /2013 Simon et al. OTHER PUBLICATIONS
2013 /0079659 Al 3 / 2013 Akhadov et al.
2013 /0131551 Al 5 / 2013 Raghunathan et al.
2013 /0158627 Al 6 / 2013 Gozani et al. Aston - Jones et al.; Role of locus coeruleus in attention and behav
2013 /0184779 Al 7 / 2013 Bikson et al . ioral flexibility; Biological Psychiatry ; 46 (9 ); pp . 1309- 1320 ; Nov.
2013/0204315 A1 8 /2013 Wongsarnpigoon et al. 1 , 1999 .
2013 /0226275 A1 8 / 2013 Duncan Axelgaard Manufacturing Co . Ltd .; Little PALS® (product infor
2013/0267761 Al 10 / 2013 Bentwich mation ); 2 pgs., printed Feb . 11 , 2013 from http ://www .axelgaard .
2013 / 0282095 A 10 / 2013 Mignolet et al.
2013/0304175 AL 11/ 2013 Voegele et al. com /prod_ little -pals.html.
2013/0318168 A1 11/ 2013 Demain et al . Axelgaard Manufacturing Co. Ltd .; PALS® Platinum Blue (product
2013/ 0325096 Al 12 / 2013 Dupelle et al. information ); 2 pgs.; printed Feb . 11 , 2013 from http ://www .
2014 / 0031895 AL 1/ 2014 Rahimi et al. axelgaard .com /prod _ pals-platinum -blue.html.
2014 /0128944 AL 5 / 2014 Stern et al. Backhaus et al., Sleep disturbances are correlated with decreased
2014 /0257449 AL 9 /2014 Helmer morning awakening salivary cortisol; Psychoneuroendocrinology ;
2014 /0277324 AL 9 / 2014 DiUbaldi et al. 29(9 ): pp . 1184 -1191; Oct. 31 , 2004.
2014 /0336728 A1 11/ 2014 Franke et al. Basta et al.; Chronic Insomnia and the Stress System ; Sleep
2015 / 0005841 A1 * 1/ 2015 Pal ... A61N 1/0476 Medicine Clinics; 2 (2 ): pp . 279 - 1291 ; ( Author Manuscript, 20
607/45
2015/0088224 A1* 3/ 2015 Goldwasser .... .. A61N 1/ 36082 pages ); Jun. 30 , 2007.
607 /45 Berlad et al., Power spectrum analysis and heart rate variability in
2015/0257970 A1* 9/2015 Mucke ............... A61N 1/0476 Stage 4 and REM sleep : evidence for state -specific changes in
601/21 autonomic dominance ; Journal of Sleep Research ; 2 (2 ): pp . 88 -90 ;
2015/0335877 AL 11/ 2015 Jeffery et al. Jun . 1 , 1993 .
2016 /0008632 AL 1/ 2016 Wetmore et al. Berridge et al., The locus coeruleus- noradrenergic system : modu
2016 / 0074657 Al 3/ 2016 Kwan et al. lation of behavioral state and state -dependent cognitive processes ;
2016 / 0317809 AL 11/ 2016 Pal et al. Brain Research Reviews; 42 ( 1 ); pp. 33 - 84 ; Apr. 30 , 2003.
2016 /0346530 Al 12 / 2016 Jeffery et al. Brown et al.; Control of sleep and wakefulness; Physiological
2016 /0346545 Al 12 / 2016 Pal et al. reviews; 92 ( 3 ); pp . 1087 - 1187 ; Jul. 1, 2012
2017 /0076414 Al 3/ 2017 Egnal et al. Brown et al.,Locus ceruleus activation suppresses feedforward
FOREIGN PATENT DOCUMENTS interneurons and reduces beta - gamma electroencephalogram fre
quencies while it enhances theta frequencies in rat dentate gyrus;
EP 1502623 B1 11/ 2007 Journals of Neuroscience ; 25 ( 8 ): pp . 1985 - 1991 ; Feb . 23 , 2005 .
EP 1551290 B1 8 /2008 Buchanan et al.; Salivary alpha -amylase levels as a biomarker of
EP 2024018 A2 2 / 2009 experienced fear; Communicative and Integrative Biology ; 3 (6 ); pp .
EP 2314346 A1 4 / 2011 525 - 527 , Nov . 1, 2010 .
EP 1559369 B1 3 / 2012 Buckley et al., On the Interactions of the Hypothalamic - pituitary
EP 2069001 B1 2 /2013 Adrenal (HPA ) Axis and Sleep : Normal HPA Axis Activity and
49061984 A 6 / 1974 Circadian Rhythm , Exemplary Sleep Disorders ; The Journal of
05031197 A 2 / 1993 Clinical Endocrinology and Metabolism ; 90 (5 ); pp . 3106 -3114 ;
10108913 A 4 / 1998 May 1 , 2005 .
2002306604 A 10 /2002 Buysse et al., The Pittsburgh Sleep Quality Index : a new instrument
200310230 A 1/ 2003 for psychiatric practice and research ; Psychiatric Research ; 28 ( 2 );
2006192302 A 7 /2006
pp . 193- 213 ; May 31 , 1989.
3129187 U 1 / 2007
200985901 A 4 /2009 Carter et al., Tuning arousal with optogenetic modulation of locus
2011118293 A 6 / 2011 coeruleus neurons; Nature Neuroscience ; 13 ( 12 ); pp . 1526 - 1533 ;
WO W092/ 06737 A1 4 / 1992 Dec. 1, 2010 .
WO W093/ 17628 A1 9 / 1993 Chaieb et al.; Transcranial alternating current stimulation in the low
WO W094/ 00188 A1 1 / 1994 kHz range increases motor cortex excitability ; Restor Neurol
WO WO94 /00189 Al 1 / 1994 Neurosci; 29 ( 3 ); pp . 167- 175; Mar. 2011 .
WO W001/78834 Al 10 /2001 Cook et al.; Trigeminal nerve stimulation in major depressive
WO W003/ 105945 A2 12 /2003 disorder: acute outcomes in an open pilot study ; Epilepsy and
WO WO2005 / 110531 Al 11 / 2005 Behavior ; 28 ( 2 ): pp . 221- 226 ; Aug. 31, 2013 .
WO WO2006 / 113801 A2 10 /2006
Coutinho et al., Musical emotions: predicting second -by -second
WO WO2006 / 138702 A2 12 /2006 subjective feelings of emotion from low -level psychoacoustic fea
WO WO2008/ 155114 AL 12 /2008
WO WO2009 /089014 Al 7 /2009 tures and physiological measurements; Emotion ; 11 ( 4 ); pp . 921
WO WO2009 / 137683 A2 11/ 2009 937 ; Aug. 2011.
WO WO2009 / 147599 Al 12 /2009 DaSilva et al., Electrode positioning and montage in transcranial
Wo WO2010 /047834 AL 4 / 2010 direct current stimulation ; J Vis Exp ; 51 ; e2744 ; 11 pgs.; May 2011 .
US 9,956 ,405 B2
Page 4
(56 ) References Cited Leproult et al ., Sleep loss results in an elevation of cortisol levels
the next evening; Sleep ; 20 ( 10 ): pp . 865 -870 ; Oct . 1997 .
OTHER PUBLICATIONS Lovibond et al., The structure of negative emotional states : Com
parison of the Depression Anxiety Stress Scales (DASS ) with the
Degiorgio et al., Trigeminal nerve stimulation for epilepsy : long Beck Depression and Anxiety Inventories; Behaviour Research and
term feasibility and efficacy ; Neurology ; 72( 10 ) : pp . 936 - 938 ; Mar. Therapy; 33(3 ); pp . 335 - 343; Mar. 31 , 1995 .
10 , 2009. Lu et al., A putative flip - flop switch for control of REM sleep ;
Degiorgio et al.; Randomized controlled trial of trigeminal nerve Nature; 441 (7093): pp. 589-594 ; Jun. 1, 2006 .
stimulation for drug -resistant epilepsy ; Neurology ; 80 (9 ); pp . 786 Magis et al., Safety and patients ' satisfaction of transcutaneous
791 ; Feb . 26 , 2013 . supraorbital neurostimulation ( SNS) with the Cefaly ( R ) device in
Digitimer Ltd .; DS2 and DS3 Isolated Stimulator (product infor headache treatment: a survey of 2 ,313 headache sufferers in the
mation ); 2 pgs.; downloaded from http : //www .digitimer. com /re general population ; The Journal of Headache and Pain , 14 ( 1 ); pp .
search / stimulators/index .htm on Feb . 10 , 2014 . 95; (manuscript version , 8 pages ) Dec . 1 , 2013
Elder et al., The cortisol awakening response — applications and McGough et al., An eight-week , open -trial, pilot feasibility study of
implications for sleep medicine; Sleep Medicine Reviews; 18 (3 ): trigeminal nerve stimulation in youth with attention - deficit/hyper
pp . 215 - 224 ; Jun . 30 , 2014 . activity disorder; Brain Stimulation ; 8 (2 ); pp. 299 - 304 ; Apr. 30 ,
Electozyme; Company and Product Information ; 3 pgs.; printed 2015 .
Feb . 11, 2014 from http ://electrozyme.com /applications/. Meltzer et al; Direct comparison of two new actigraphs and
Eschenko et al.; Noradrenergic neurons of the locus coeruleus are polysomnography in children and adolescents; Sleep ; 35 ( 1 ); pp.
phase locked to cortical up -down states during sleep ; Cerebral 159 - 166 ; Jan . 1, 2012 .
Cortex ; 22 (2 ); pp . 426 -435 ; Feb . 1, 2012 . Nash et al., Differential activation of the human trigeminal nuclear
Feurra et al.; Frequency specific modulation of human complex by noxious and non -noxious orofacial stimulation ; Human
somatosensory cortex ; Front Psychol; 2 ( 13 ); 6 pgs.; Feb . 2011 . Brain Mapping; 30 ( 11 ); pp. 3772-3782 ; Nov . 1, 2009.
Franowicz et al.; Treatment with the noradrenergic alpha- 2 agonist Nieuwenhuis et al.; Decision making, the P3 , and the locus
clonidine , but not diazepam , improves spatial working memory in coeruleus- norepinephrine system ; Psychological Bulletin ; 131 ( 4 );
normal young rhesus monkeys, Neuropsychopharmacology ; 21 (5 ); pp . 510 - 532 ; Jul . 2005 .
pp. 611 -621; Nov. 1, 1999 . Parvizi et al.; Consciousness and the brainstem ; Cognition ; 79 ( 1 ) :
Garraway et al.; Modulatory actions of serotonin , norepinephrine, pp . 135 -60 ; Apr. 30 , 2001.
dopamine , and acetylcholine in spinal cord deep dorsal horn neu Paulus, W .; Transcranial electrical stimulation (tES - DCS; tRNS ,
rons; Journal of Neurophysiology ; 86 (5 ); pp . 2183 - 2194 ; Nov . 1, VACS ) methods; Neuropsychol Rehabil .; 21 (5 ); pp . 602 -617 ; Oct.
2001. 2011.
GOFLOW ; DCS Kit ; product information ; 9 pgs.., printed Feb . 10 , Penzel et al.; Dynamics of Heart Rate and Sleep Stages in Normals
2014 (http ://flowstateengaged .com /). and Patients with Sleep Apnea ; Neuropsychopharmacology ; 28 ( S1) ;
Golestanirad et al; Analysis of fractal electrodes for efficient neural pp. 348 -553; Jul. 1, 2003.
stimulation ; Frontiers in Neurengineering; 6 (3 ); 10 pages; Jul. 2013 . Piquet et al.; Supraorbital transcutaneous neurostimulation has
Gracenote ; Timeline -metadata -api ; 3 pages; retrieved from the sedative effects in healthy subjects; BMC Neurology ; 11( 1) ; p . 135 ;
Internet Jul. 7 , 2015 ; (https:// github . com / gracenote /timeline (manual transcript, 8 pages ); Oct. 28 , 2011.
metadata -api/blob /master/README.md) . Plewnia et al.; Enhancement of human cortico- motoneuronal
Granger et al., Salivary alpha -amylase in biobehavioral research : excitability by the selective norepinephrine reuptake inhibitor
recent developments and applications ; Annals of the New York reboxetine ; Neuroscience Letters ; 330 (3 ); pp . 231 - 234 ; Sep . 27 ,
Academy of Sciences ; 1098 ( 1 ); pp . 122 - 144; Mar. 1, 2007. 2002 .
Grindhouse Wetware ; Thinking Cap ; product information ; 1 pg.; Prausnitz ; The effects of electric current applied to skin : a review for
printed Feb . 10 , 2014 (http ://www . grindhousewetware . com / transdermal drug delivery ; Advanced Drug Delivery Reviews; vol.
thinkingcap .html). 18 ; pp . 395 -425 ; Feb . 8 , 1996 .
Gummadavelli et al., Neurostimulation to improve level of con Pusch et al.; Electrical stimulation of the vestibular system prevents
sciousness in patients with epilepsy . Neurosurgical Focus; 38 (6 ); postoperative nausea and vomiting; Acta Annesthesiol Scand .;
pp . E10 ; (manuscript version , 14 pages ); Jun . 2015 . 44 (9 ); pp . 1145 - 1148 ; Oct. 2000 .
Hajos et al., Norepinephrine but not serotonin reuptake inhibitors Riemann et al., The hyperarousal model of insomnia: A review of
enhance theta and gamma activity of the septo -hippocampal system ; the concept and its evidence ; Sleep Medicine Reviews; 14( 1 ); pp .
Neuropsychopharmacology ; 28 (5 ); pp . 857-864 ; May 1, 2003. 19 - 31 ; Feb . 28, 2010 .
Hass et al., Waking with the hypothalamus. Pflugers Arch R Eur. J . Rill et al., Pedunculopontine arousal system physiology - implica
Physiol.; 463 ( 1 ): pp . 31-42; Jan . 1, 2012 . tions for insomnia ; Sleep Science ; 8 (2 ); pp . 92 - 99 ; Jun . 30 , 2015 .
Herwig et al., Intracortical excitability is modulated by a norepi Rohleder et al., Psychosocial stress-induced activation of salivary
nephrine -reuptake inhibitor as measured with paired -pulse alpha-amylase : an indicator of sympathetic activity ; Annals of the
transcranial magnetic stimulation ; Psychopharmacology (Berl); New York Academy of Sciences ; 1032 ( 1 ); pp . 258 - 263 ; Dec . 1 ,
164 ( 2 ): pp . 228 - 232 ; Nov. 18 , 2002 . 2004 .
Hirotsu et al., Interactions between sleep , stress, and metabolism ; Saiote et al., High -frequency TRNS reduces BOLD activity during
From physiological to pathological conditions; Sleep Science; 8 (3); visuomotor learning; PLOS one; 8( 3 ); e59669; 8 pgs.; Mar. 2013 .
pp. 143- 152 ; Nov . 2015 . Sara ; The locus coeruleus and noradrenergic modulation of cogni
Horvath et al., Evidence that transcranial direct current stimulation tion ; Nature Reviews Neuroscience; 10 (3 ): pp . 211- 223 . Mar. 1 ,
(UDCS) generates little - to -no reliable neurophysiologic effect 2009.
beyond MEP amplitude modulation in healthy human subjects: A Schmidt et al., Adrenaline rush : the role of adrenergic receptors in
systematic review ; Neuropsychologia ; 66 : pp . 213 - 236 ; Jan . 31 , stimulant-induced behaviors; Molecular Pharmacology ; 85( 4 ): pp .
2015 . 640 -650 ; Apr. 1, 2014 .
Just et al.; Bold responses to trigeminal nerve stimulation ;Magnetic Schutter et al., Brain oscillations and frequency - dependent modu
Resonance Imaging ; 28 (8 ): pp . 1143 - 1151 ; Oct. 31, 2010 . lation of cortical excitability ; Brain Stimulation ; 4 (2 ); pp . 97 - 103 ;
Kanai et al., Frequency -dependent electrical stimulatioin of the Apr. 2011 .
visual cortex ; Curr. Biol.; 18 (23 ); pp . 1839 - 1843 ; Dec . 9 , 2008 . Seugnet et al., Identification of a biomarker for sleep drive in flies
Kubota et al., Role of the brain stem in cardiovascular changes and humans; Proceedings of the National Academy of Sciences ;
induced by stimulation of the trigeminal nerve; Anesthesia Progress ; 103 (52 ); pp . 19913 - 19918 ; Dec . 26 , 2006 .
36 ( 4 - 5 ); pp . 236 -237 ; Jul. 1989. Shiozawa et al., Transcutaneous vagus and trigeminal nerve stimu
Lee et al., Neuromodulation of Brain States; Neuron ; 76 ( 1): pp . lation for neuropsychiatric disorders : a systematic review ; Arquivos
209 - 222 . Oct . 4 , 2012 . de neuro -psiquiatria ; 72 (7 ) : pp . 542 - 547; Jul. 2014 .
US 9,956 ,405 B2
Page 5
( 56 ) References Cited Tyler et al., U . S . Appl. No. 61/663,409 entitled " Device and
Methods for Noninvasive Neuromodulation Using Targeted
OTHER PUBLICATIONS Transcranial Electrical Stimulation ,” filed Jun . 22 , 2012 .
Tyler et al., U . S . Appl. No . 62 / 166 ,674 entitled “ Systems and
Siegel; Brain mechanisms that control sleep and waking. Naturwis Methods for Suppression of Stress Responses by Transdermal
senschaften ; 91 (8 ); pp . 355 - 365 ; Aug. 1, 2004 . Electrical Neuromodulation ,” filed May 26 , 2015 .
Somana et al.; Cerebellar afferents from the trigeminal sensory Upadhyay et al.; Noninvasive mapping of human trigeminal brain
nuclei in the cat. Brain Res., 38 ( 1) ; pp. 57 -64; Jan . 1980 . stem pathways ;Magnetic Resonance in Medicine; 60 ( 5 ): pp . 1037
STD Pharmaceutical Products; Idrostar intophoresis machine (prod 1046 ; Nov . 1, 2008 .
Van Stegeren et al., Salivary alpha amylase as marker for adrenergic
uct and use information ); 9 pgs.; Dec. 2011 (printed Feb . 11 , 2014 activity during stress : effect of betablockade ;
from http ://www . iontophoresis.info / instructions/). Psychoneuroendocrinology ; 31( 1); pp . 137- 141, Jan . 31, 2006 .
Strassman et al; Response of brainstem trigeminal neurons to Voisin et al., Nociceptive stimulation activates locus coeruleus
electrical stimulation of the dura ; Brain Research ; 379 (2 ): pp . neurones projecting to the somatosensory thalamus in the rat ; The
242 -250 ; Aug. 6 , 1986 . Journal of Physiology ; 566 ( 3 ); pp . 929 - 937 ; Aug. 1 , 2005 .
Tanaka et al., Salivary alpha -amylase and cortisol responsiveness Voss et al.; Induction of self awareness in dreams through frontal
following electrically stimulated physical stress in bipolar disorder low current stimulation of gamma activity ; Nature Neuroscience;
patients; Neuropsychiatric Disease and Treatment; 8 ; pp . 1899 17 (6 ); pp . 810 - 812 ; Jun . 1, 2014 .
Watson et al., Development and validation of brief measures of
1905; Jan . 1, 2013 . positive and negative affect: the PANAS scales ; Jouranl of Person
Terney et al., Increasing human brain excitability by transcranial ality and Social Psychology ; 54(6 ); pp . 1063- 1070 ; Jun . 1988 .
high - frequency random noise stimulation ; The Journal of Neuro Weiss et al; Validity of Activity -Based Devices to Estimate Sleep ;
science; 28 (52); pp . 14127 - 14155 ; Dec. 2008 . Journal of Clinical Sleep Medicine : 6 ( 4 ); pp . 336 -342 ; Aug. 2010 .
Thoma et al., Acute stress responses in salivary alpha -amylase Goldwasser et al., U .S . Appl. No. 15 /264, 224 entitled “ Apparatuses
predict increases of plasma norepinephrine ; Biological Psychology ; and methods for neuromodulation ,” filed Sep . 13 , 2016 .
91( 3 ): pp. 342-348 ; Dec . 31, 2012 . Charlesworth et al., U . S . Appl. No. 15 /384 ,249 entitled “ Appara
Tremblay et al., Uncertain Outcome of Prefrontal tDCS ; Brain tuses and methods for transdermal electrical stimulation of nerves to
Stimulation ; 7 (6 ): pp . 773 - 783 ; Dec . 31, 2014 . modify or induce a cognitive state,” filed Dec . 19 , 2017 .
Trevizol et al., Trigeminal Nerve Stimulation ( TNS) forGeneralized Jeffery ; U . S . Pat. Appl. No. 15 / 380 ,028 entitled “ Electrodes having
Anxiety Disorder: A Case Study ; Brain Stimulation ; 8 ( 3 ) : pp . surface exclusions,” filed Dec . 15 , 2016 .
659 -660 ; Jan . 1 , 2015 . Tyler et al., U . S . Appl. No . 15 / 460, 138 entitled “ Systems and
Trevizol et al., Trigeminal Nerve Stimulation ( TNS) for Post methods for transdermal electrical stimulation to improve sleep ,”
traumatic Stress Disorder : A Case Study; Brain Stimulation ; 8 ( 3 ) : filed Mar. 15, 2017.
pp . 676 -678; Jan. 1, 2015 Pal et al., U .S . Appl. No. 14/ 956 , 193 entitled “ Transdermal elec
Turi et al., Both the cutaneous sensation and phosphene perception trical stimulation devices for modifying or inducing cognitive
are modulated in a frequency -specific manner during transcranial state ," filed Dec . 1, 2015 .
alternating current stimulation ; Rester. Neurol. Neurosci.; 31( 3 ); pp . Tyler et al.; U . S . Appl. No. 15 /536 , 148 entitled “ Methods and
275 - 285 ; Jan . 2013 . apparatuses for transdermal stimulation of the outer ear,” filed Jun .
Tyler et al.; Transdermal neuromodulation of noradrenergic activity 15 , 2017 .
suppresses psychophysiological and biochemical stress responses in Tyler et al., U . S . Appl. No . 15 /536 , 151 entitled “ Systems and
humans ; Scientific Reports ; 5 ; (manual transcript, 22 pages ); Feb . 8 , methods for transdermal electrical stimulation to improve sleep ,”
2015 . filed Jun . 15 , 2017 .
Tyler et al.; U . S. Appl. No. 61/550 ,334 entitled “ Improvement of
Direct Communication ,” filed Oct. 21, 2011 . * cited by examiner
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STIMULATION AT THE NECK TO INDUCE clinical applications, including treatment of pain , depres
NEUROMODULATION sion , epilepsy, and tinnitus . In at least some cases of TES
therapeutic use, more data concerning the efficacy of TES in
CROSS REFERENCE TO RELATED 5 treatment is needed . Despite the research to date on TES
APPLICATIONS neuromodulation , existing systems and methods for TES are
lacking in at least some cases regarding the design and use
This patent application claims priority to U .S . provisional of effective TES waveforms. Available systems are limited
patent application No . 62/ 431, 365 , filed Dec . 7 , 2016 , titled regarding the design and delivery of TES waveforms.More
“ TRANSDERMAL ELECTRICAL STIMULATION AT 10 over, available systems do not permit the user to modulate
THE NECK TO INDUCE NEUROMODULATION .” This a predetermined/ preconfigured electrical stimulation proto
application is herein incorporated by reference in its entirety. col.
For example , U .S . Pat. No. 8 ,554 ,324 to Brocke discloses
INCORPORATION BY REFERENCE a mobile system for TES auto -stimulation by a user. Brocke
15 further describes an embodiment wherein a wired or wire
All publications and patent applications mentioned in this less remote control is used to control an electrical stimula
specification are herein incorporated by reference in their tion generator, as well as the use of smartphones, cellular
entirety to the same extent as if each individual publication telephones , or PDAs as a remote control. However, the
or patent application was specifically and individually indi- systems and methods described by Brocke are lacking in at
cated to be incorporated by reference . 20 least some instances for defining , acquiring , and / or deliver
ing effective TES waveforms to a user.
FIELD Unfortunately, the majority of the devices , including
wearable devices , described to date must be positioned on
Described herein are methods and apparatuses for nonin - one more likely two body locations , often including the face
vasive neuromodulation of a subject to induce relaxation , 25 and head , which can be uncomfortable and visually unap
calm , mental clarity , and associated mental and physical pealing to many consumers. Further, the stimulator electron
states. These methods and devices in particular include a ics interfaces for such devices may be cumbersome, and the
neck -worn apparatus which need only contact the user in a small size may limit the power and battery life . Even
single location at the back of the users neck while coupled so -called self- contained devices may project from the body
( e. g ., magnetically ) to controller and / or power source . 30 ( including the face ) making them uncomfortable , and may
be easily disrupted .
BACKGROUND In addition , the stimulation parameters (e.g., waveforms
described to date have proven to be difficult to generalize
Noninvasive neuromodulation technologies that affect across users ; stimulation parameters that are effective for
neuronal activity can modulate the pattern of neural activity 35 one set of users may be ineffective and /or uncomfortable
and cause altered behavior, cognitive states , perception , and particularly when applied to the head and face ) for other
motor output without requiring an invasive procedure . For users .
example , transcranial/transdermal electric stimulation (here - Finally, most electrodes for TES (and TENS , transcuta
inafter “ TES ” ) through scalp electrodes has been used to neous electrical nerve stimulation systems require single
affect brain function in humans in the form of transcranial 40 use electrodes applied to the skin (or scalp ) by an adhesive .
alternating current stimulation (hereinafter “ tACS ” ), tran - Such electrodes may be reused for a limited number of uses ,
scranial direct current stimulation (hereinafter “ DCS ” ), however they are difficult or impossible to clean , and may
cranial electrotherapy stimulation (hereinafter “ CES ” ) , and dry out, interfering with their ability to reliable make elec
transcranial random noise stimulation (hereinafter “ tRNS” ). trical contact with the skin .
Systems and methods for TES have been disclosed (see for 45 It would be beneficial to provide apparatuses for effective
example , Capel U . S . Pat. No. 4 ,646 ,744; Haimovich et al. neuromodulation (e . g ., to affect mood and/ or mental state ) of
U .S . Pat. No . 5 ,540 ,736 ; Besio et al. U . S . Pat. No. 8 , 190 , a wide number of users that may be worn discretely and
248; Hagedorn and Thompson U . S . Pat. No . 8 ,239,030 ; comfortably . In particular, such apparatuses ( e. g ., systems
Bikson et al. U . S . Patent Publication 2011/0144716 ; and and devices ) may also be easily operated and attached to the
Lebedev et al. U . S . Patent Publication 2009/ 0177243 ). DCS 50 user, without disrupting the user's hair , skin , glasses, etc. It
systems with numerous electrodes and a high level of would also be beneficial to provide electrodes , and in
configurability have been disclosed (see for example Bikson particular electrodes for TES apparatuses , that may be
et al. U . S . Patent Publications 2012 /0209346 , 2012 / re -used , cleaned and / or rewetted. Described herein are meth
0265261, and 2012 /0245653), as have portable TES systems ods and apparatuses that may address these needs .
for auto - stimulation ( Brocke U . S . Pat. No . 8 ,554 , 324 ) . Other 55
portable systems include U .S . patent application Ser. No . SUMMARY OF THE DISCLOSURE
14 /639,015 , titled “ TRANSDERMAL ELECTRICAL
STIMULATION DEVICES FOR MODIFYING OR In general, described herein are methods and apparatuses
INDUCING COGNITIVE STATE ” , filed Mar. 4 , 2015 , for the application of transdermal electrical stimulation
which is a continuation of U .S . patent application Ser . No. 60 ( TES ) in order to modulate a user's cognitive (e.g., mental)
14 /320 ,461, titled “ TRANSDERMAL ELECTRICAL state , and in particular to induce a state of calm or relaxation .
STIMULATION DEVICES FOR MODIFYING OR The apparatuses described herein may include a neck
INDUCING COGNITIVE STATE ,” filed on Jun . 30 , 2014 , applied electrode pad (also referred to herein as an electrode
now U . S . Pat. No . 9, 002,458 , and U . S . patent application patch ) thatmay automatically couple with a neck -worn TMS
Ser. No. 14 /091 ,121, titled “ WEARABLE TRANSDER - 65 controller. The electrode patch may be worn (e .g., adhe
MAL ELECTRICAL STIMULATION DEVICES AND sively coupled ) to the skin of a neck to make electrical
METHODS OF USING THEM ” , filed on Nov . 26 , 2013 . contact with the midline of the back of user 's neck . The
US 9 ,956 ,405 B2
electrode pad may include two or more electrodes for arranged adjacent to each other and separated by between 5
contacting the user 's skin . A neck -worn controller ( TES mm and 60 mm apart in a line that is at an angle (e.g .,
stimulator ) may be configured as a cord , band , wire , torque between 90° or perpendicular and 15 degrees ) to an axis of
(torc ), necklace , loop , strap , or the like , and may be rigid or the U - shaped torque body, and a skin -contacting reusable
semi-rigid . The neck -worn controller may automatically 5 and rewettable electrode on each of the electrode supports
self- couple ( e . g., via a magnetic force coupler ) to the elec - configured to be secured against the user ' s neck when the
trode pad , and may be worn around the subject's neck, e.g., torc body is placed around the users neck ; and wherein the
completely or partially around the subject 's collar and/ or torc body encloses a control circuitry , a power source and a
shoulders . The controller ( TES stimulator ) may controllably wireless communication circuitry .
apply one or more waveforms to the electrodes of the 10 In general, the spacing between the electrodes ( or elec
electrode pad to deliver TES . The waveforms applied are trical contacts ) connecting to the electrodes ( as well as the
adapted to induce or enhance a cognitive state such as relative arrangement of the electrodes on the user 's neck ) in
relaxation and/ or calm . order to evoke a relaxed state may be important, and is
Any of these TES apparatuses (devices and systems) typically between 5 mm and 80 mm apart ( e. g ., 5 mm and
described herein may include one or more re - usable elec - 15 70 mm , 5 mm and 60 mm , 5 mm and 50 mm , 5 mm and 40
trodes , including cleanable ( or self-cleaning ), re -wettable mm , 5 mm and 30 mm , 5 mm and 20 mm , 10 mm and 70
( or self-re -wetting) electrodes. For example , a re -wettable mm , 10 mm and 60 mm , 10 mm and 50 mm , 10 mm and 40
electrodemay include a " dry ” electrode that is automatically mm , etc .). This spacing may be edge - to - edge ( nearest edge
wetted before use by applying a conductive material (con - to nearest edge ) or center -to - center between the two elec
ductive liquid , such as an aqueous solution , salt solution , 20 trode contacts and / or electrodes.
conductive gel , etc .) by a vapor. In particular , an electrode Any of these apparatuses may include a control (e .g.,
may be integrated with a vaporizer ( e . g ., piezoelectric vapor- on /off, rest, start/ stop , rewet, etc . ) on the torc body ; the
izer , thermal vaporizer, etc . ) that can saturate the electrode' s controlmay be electrically connected to the control circuitry
skin - contacting region . The electrode' s skin -contacting and may be any appropriate control, including but not
region may be a porousmaterial (e . g ., sponge , etc .). In some 25 limited to a button , dial, touchpad , slider, etc .
variations the apparatus may include a reservoir of the As mentioned , the skin - contacting electrode on each of
conducive material in contact with the vaporizer thatmay be the electrode supports may comprise a re -wettable electrode ,
used to automatically wet the skin -contacting region . In including self-re -wetting electrodes and /or automatically
some variations the apparatus may configured to detect the re -wetting electrodes , self- cleaning electrodes, or the like.
wetness of the skin - contacting material and regulate the 30 For example , the skin -contacting electrode on each of the
activity of the vaporizer based on feedback from the electrode supports may include a mist generator (e .g., vapor
detected wetness ( e. g., the detected resistance or conductiv - izer ), and may be coupled to a fluid reservoir on the torc
ity of the skin - contacting region or the electrical contact body . The mist generator may be configured to wet one or
with a skin surface ). Any of the reusable (e . g ., automatically both of the skin -contacting electrodes . For example a mist
re -wettable and/ or self-cleaning) electrodes described herein 35 generator comprises a piezo driver configured to generate a
may be used in whole or in part as part of a skin -contacting mist. In some variations the mist generator may be a piezo
electrode, including as part of a physiological monitoring that is configured to be driven by the same circuitry driving
system ( e . g ., electrocardiogram , electroencephalogram , the electrical stimulation ( e . g ., TES ), e . g ., at a frequency
electromyogram , etc . ). In particular, these devices may be between 100 KHz to 2 MHz (or greater ).
part of a TES apparatus, as mentioned . 40 The body (torc body ) may be partial rigid , including
For example , described herein are neck -worn controller having one or more rigid portions connected by a flexible
devices for applying transdermal electrical stimulation region or regions . The torc body may be flexible . The torc
( TES ) to the back of a subject's neck to modify a user 's body may be any appropriate shape, including U -shaped or
cognitive state and induce a relaxed state . These devices C - shaped . The torc body may include a charging port for
may include: a rigid or semi- rigid torc body configured to be 45 charging a battery within the torc body. The torc body may
worn around the user 's neck ; an electrode- coupling region at be an elongate body that generally extends from a first end
a middle region of torc body, wherein the electrode-coupling to a second end , and fits over the user 's neck while holding
region comprises : a pair of electrode supports arranged the electrodes to the back of the user' s neck . The torc body
adjacent to each other and separated by between 5 mm and may include a hinge on the torc body. The electrode
60 mm apart, and a skin - contacting electrode on each of the 50 coupling region may be rigid . The control circuitry , the
electrode supports configured to be secured against the power source and the wireless communication circuitry may
user ' s neck when the torc body is placed around the users be located at an end of the elongate body. The control
neck ; and wherein the torc body encloses a control circuitry, circuitry and wireless communication circuitry may be
a power source and a wireless communication circuitry. In located at a first end region of the elongate body and the
any of the apparatuses described herein an electrode support 55 power source may be located at a second end region of the
may be an electrical contact (or may include an electrical elongate body .
contact) connecting a skin -contacting electrode to the con - As will be described in more detail below , any of the
trol circuitry of the apparatus. skin -contacting electrodes described herein may be fixed to
For example , a neck -worn controller device for applying the neck -worn TES apparatus or may be removably coupled
transdermal electrical stimulation ( TES ) to the back of a 60 to the neck -worn TES apparatus ( e . g ., to the electrode
subject' s neck to modify a user ' s cognitive state and induce supports ). For example , the electrodes may be removable
a relaxed state , may include : a rigid or semi- rigid torc body and replaceable. The electrode - coupling region may com
configured to be worn around the user's neck , the torc body prise a pair of magnetic attachments. Alternatively or addi
extending in a U -shape from a first end to a second end ; an t ionally , the skin - contacting electrodes may self - adhere to
electrode- coupling region near middle region of torc body 65 the TES apparatus allowing for electrical and physical
between the first and second ends, wherein the electrode connection via an adhesive ,mechanical ( e. g ., hook -and - loop
coupling region comprises: a pair of electrode supports fasteners, artificial setae, etc .), etc .
US 9 ,956 ,405 B2
Any of the neck -worn TES apparatuses described herein tion , alternatively, the waveform may be held for longer
may include one ormore speakers and / or an audio connector durations ( e . g ., 1 minute to 5 minutes , 1 minute to 10
(jack ) for coupling to a speaker or headphones . minutes , 1 minute to 20 minutes , 1 minute to 30 minutes , 1
In general, any of the neck -worn TES apparatuses may minute to 40 minutes , etc.). For example , the shape of the
include control circuitry for driving TES through the elec - 5 amplitude modulation envelope may be changed ( e .g ., from
trodes and / or regulating the apparatus ( including the wetting a sinusoidal envelope to a rectangular envelope , a saw tooth
of the electrodes in some variations). For example , the envelope , a triangular envelope, a stair - case envelope , etc .) ,
control circuitry may be configured to deliver electrical and the frequency of the amplitude modulation may change
energy between the pair of electrodes ( or electrical contacts ), separately or at the same time. In some variations the shape
wherein the electrical energy comprises a carrier wave 10 of the amplitudemodulation envelope is changed by adjust
having a frequency that is greater than 250 Hz that is ing one or more of: 1 ) the symmetry ratio (meaning the wave
amplitude modulated at a frequency that is ten percent or form in timemay be non -symmetrical in the time axis ; the
less the frequency of the carrier wave , further wherein the ratio is an estimate of how non - symmetrical it is ), or 2 ) the
amplitude modulation is varied at least once every 40 flat ratio (meaning the portion (s ) of the waveform that
seconds. 15 remains unchanged in amplitude over as a portion of the
Any of the apparatuses and method described herein may wave period ), etc . In any of the method and apparatuses
be used (and may be further configured for use ) to enhance (configured to perform these methods) described herein , the
relaxation . Alternatively or additionally , these apparatuses waveforms duration may be controlled by the subject; thus
and methods may be used to lower stress . Stress may be subject may continue to apply the waveform until an effect
monitored (and in some variations used as feedback , includ - 20 is achieved . For example , a waveform may be applied in a
ing visual or audio feedback , such as displaying an indicator loop that is repeated until terminated by the subject.
of the user ' s stress level (blood pressure , heart rate , skin In some variations , the rise time of the waveform ( s )
conductance , etc . ) and /or providing controlling feedback applied may be controlled to minimize discomfort . For
(increasing or decreasing stimulation , modulating a stimu- example , the rise -time of a basic pulse waveform applied
lation parameter , etc .). Thus, an indicator of stress (or mood ) 25 may be between 1 and 20 microsecond . The rise -time of the
may be used as a control input for controlling/adjusting pulse may affect both comfort and efficacy ; based on pre
stimulation including turning on /off , adjusting a parameter liminary data , it may be beneficial to vary the rise time
of electrical stimulation (frequency , current, duty cycle , between 1 - 20 us , including varying the rise time continu
peak amplitude , rise time, duration , etc .). Alternatively or ously between 1 and 20 us , or picking a rise time that is
additionally, any of the apparatuses and methods described 30 between 1 and 20 us and using this , and /or allowing the
herein may be used to elevate mood . Thus, in general, any device and / or use to adjust the rise time ( e . g ., between 1 - 20
of the apparatuses and methods described herein may be us ) during application of the waveforms.
useful to reduce stress , reduce anxiety , improve sleep , and /or As mentioned , the apparatuses described herein include
improve mood. neck -worn controller devices for applying transdermal elec
For example , any of the apparatuses and methods 35 trical stimulation (TES ) to the back of a subject's neck to
described herein may be used to improve sleep ( e .g ., one or modify a user 's cognitive state and induce a relaxed state .
more of: sleep quality, sleep onset, sleep duration , sleep For example , described herein are neck -worn (also referred
depth / stage , etc. ). An indicator of sleep (e . g ., sleep staged to herein as “ neck wearable ” ) that may be comfortably worn
sleep level) may be used as a control input for controlling around the user 's neck and may include : an elongate body
adjusting stimulation including turning on /off, adjusting a 40 configured to be worn at least partially around the user 's
parameter of electrical stimulation ( frequency, current, duty neck ; an electrode -coupling region on the elongate body , the
cycle , peak amplitude, rise time, duration , etc.). electrode -coupling region comprising : a pair of electrical
The methods described herein may be used to apply contacts , and at least one self- connecting (e . g ., magnetic ,
neurostimulation to one or more nerves ( e.g ., nerve bundles ) adhesive , etc .) attachment configured to automatically
though the skin of the subject ' s neck at two nearby ( e . g ., 45 couple the electrical contacts with a complimentary electri
adjacent) locations near the cervical spinal region , such as cal contact on an electrode pad worn on the user ' s neck
beneath the hairline but above the C7 cervical region . The when the magnetic attachment is placed adjacent to the
two locations may be separated by between about 0 . 5 and electrode pad ; and wherein the elongate body encloses a
2 .5 inches apart from each other. A single electrode pad may control circuitry , a power source such as a battery, a high
be used to make contact with both sites . 50 voltage source of power for neural stimulation greater than
The TES waveforms used to apply energy herein may 20 volts , and a wireless communication circuitry .
include a carrier frequency that is between 250 Hz and 50 Any of the neck -worn controller devicesmay include one
kHz, and may typically an amplitude between about 1 -40 or more controls on the body of the device . For example , a
mA (e. g ., peak amplitude of between 10 mA and 35 mA, neck -worn controller may include a switch , dial, button ,
between 10 mA and 30 mA , etc. ). The carrier waves may be 55 slider, etc . The controller may control one ormore of ( and /or
asymmetric and/or biphasic . Significantly, the applied TES multiple controls may control) : power ( e . g ., on /off / standby) ,
waveforms are modulated by an amplitudemodulation enve - intensity of the TES being applied , communication with a
lope that comprises a lower frequency that is at least 10x remote ( e . g ., wireless) controller, playing of the TES ( e . g .,
lower than the frequency of the carrier wave (e . g ., a modu - TES start/pause / stop ), selection of a TES waveform , etc .
lation envelope between 10 - 1 kHz, e . g ., between 10 - 900 Hz, 60 Any of the neck -worn controller devices described herein
between 10 - 850 Hz, between 10 - 800 Hz, etc ., and a carrier may include one or more output such as a display ( e. g .,
wave of greater than 2250 Hz, e . g ., greater than 300 Hz, 350 LCD , LED , etc .) or other visual output (LED ), a tactile
Hz, 400 Hz, 450 Hz, 500 Hz, 550 Hz, 600 Hz, 650 Hz, 700 output ( haptic , e. g ., vibrational output, etc .).
Hz, 750 Hz, 800 Hz, 850 Hz, 900 Hz, 950 Hz, 1 kHz, 2 kHz, The elongate body may be stiff, flexible , or semi-stiff , and
3 kHz, 4 kHz, 5 kHz, 6 kHz, etc ., and particularly greater 65 may include both stiff and flexible regions (e .g., stiff regions
than 5 kHz ). The applied waveform may be varied every 5 connected by flexible regions) . For example , the elongate
to 60 seconds, typically by varying the amplitude modula body may be flexible so that it generally retains its shape but
US 9 ,956 ,405 B2
can be “ opened ” (e.g ., when the device is U - or C - shaped ) length of the elongate body . This separation may allow them
to fit over a user's neck . In general, the elongate body may to properly and automatically engage ( e.g ., self-engage )
be U -shaped or C -shaped . In some variations the elongate with the electrode pads described herein for TES of the neck
body include a hinge or hinges thatmay be used to open the to induce relaxation .
elongate body for placing it on / taking it off of the user 's 5 Any of the neck -worn devices described herein may be
neck . configured to include one or more speakers (e. g., head
Any of the apparatuses described herein may include a phones, etc .). In some variations the apparatuses described
charging port on the elongate body ( e . g ., micro USB port). herein may be configured to include one or more ear -based
Alternatively or additionally any of these apparatuses may electrodes .
include a non -contact charger ( e.g ., inductive charging, etc .) 10 In general, the control circuitry may be configured to
or the like. deliver electrical energy (e . g ., TES ) between the pair of
As mentioned , in general, any of the neck -worn controller electrical contacts in order to evoke relaxation in a user by
devices described herein may include an electrode-coupling applying TES at the midline of the user's neck between the
region that may be used to secure the neck -worn controller C1 and T2 region ( e. g ., C3 and T1 , C3 and T2, etc. ). For
to the user via a connection to an electrode pad that can be 15 example the control circuitry may be configured to deliver
separately worn on the user 's neck . For example , an elec - electrical energy comprising a carrier wave having a fre
trode-coupling region may be located in a middle region of quency that is greater than 250 Hz that is amplitude modu
the elongate body. The electrode - coupling region may gen - lated at a frequency that is ten percent or less the frequency
erally be rigid or stiff so that it does not shift during wearing of the carrier wave , further wherein the amplitude modula
or dislodge the coupling attachments ( e . g ., attachment 20 tion is varied at least once every 60 seconds ( e . g ., once
between the electrical contact and a connector on an elec - every : 50 sec , 45 sec , 40 sec , 35 sec , 30 sec , etc .).
trode pad . Either the connector on the electrode pad or the In any of the apparatuses ( e. g ., systems) described herein ,
electrical contact on the neck -worn controller, or both , may software , firmware, or hardware may be separate from the
include a magnet and/ or a magnetic material (that may be neck -worn device and may wirelessly connect with the
attracted to a magnet, such as steel, etc. ). This may allow 25 device to regulate , control, select, and / or modify the TES
self- connection between the two. The magnetic material, waveforms applied by the apparatus. For example , a user
when included , may be any appropriate magnetic material, electronics device (e . g ., a handheld user electronics device
including " static ” magnetic material (e . g ., ferrous or mag such as a smartphone , wearable electronics, etc .) may wire
netic material) and/or electromagnetic materials . lessly communicate with the neck -worn controller to trans
In some variations the electrode - coupling region is at an 30 mit or deliver the TES waveform and /or to modify the TES
end of the elongate body. waveform ( e.g ., increase /decrease intensity, etc.) and /or
In general , any of the apparatuses described herein may start/ stop /pause operation of the TES waveform delivery.
include a self -connecting or self- engaging connector draw - A neck -worn controller device for applying transdermal
ing together the electrode pad and the neck -worn apparatus electrical stimulation ( TES ) to the back of a subject's neck
so that an electrical and /or mechanical connection is made 35 to modify a user ' s cognitive state and induce a relaxed state
between the two. Although the primary self- engaging con - may include: an elongate body configured to be worn around
nectors described herein are magnetic connectors , any the user 's neck ; a rigid electrode - coupling region on the
appropriate connector may be used , including adhesive , elongate body, the electrode- coupling region comprising : a
and /or mechanical self- attaching couplings. However in pair of electrical contacts adjacent to each other, and at least
some variations the electrode- coupling region may comprise 40 onemagnetic attachment configured to automatically couple
a pair of magnetic attachments . the electrical contacts with a complimentary electrical con
The electrical contact may be integrally formed with the tact on an electrode pad worn on the user ' s neck when the
magnetic attachment. For example , the electrical contact magnetic attachment is placed adjacent to the electrode pad ;
may be made through a magnetic ( including ferrous) mate and control circuitry, a power source and a wireless com
rial. In some variations the connector and / or the electrical 45 munication circuitry .
contacts may be made of an electrically conductive material Also described herein are systems for applying transder
forming the electrical pathway surround by or adjacent to a mal electrical stimulation ( TES ) to the back of a subject' s
magnetic connector ( e . g ., the electrical contact may be neck to modify a user ' s cognitive state and induce a relaxed
adjacent to or surrounded by the magnetic attachment). One state , that include an electrode pad to be worn on the back
or more self -connecting connectors (magnets ) may be 50 of the neck and a neck -worn controller ( and in some
included . variations control software that operates on a controller of a
In any of these variations , the power source and the user electronic device and wirelessly communicates with the
wireless communication circuitry are located at an end of the neck -worn controller ).
elongate body. For example, the control circuitry and wire - For example , a system for applying transdermal electrical
less communication circuitry may be located at a first end 55 stimulation (TES) to the back of a subject's neck to modify
region of the elongate body and the power source may be a user 's cognitive state and induce a relaxed state may
located at a second end region of the elongate body . In include : an adhesive electrode pad comprising a first elec
general, when the neck -worn controller device is configured trode and second electrode on a first side, and a first
to be worn around both sides of a user 's neck (e . g ., is connector electrically connected to the first electrode and a
U - shaped ) , then the two ends ( arms) of the U - shaped body 60 second connector electrically connected to the second elec
may be balanced in shape, size and / or weight. trode , wherein the first and second connectors are on a
The electrical contacts may be further adapted to connect second side opposite from the first side ; and a neck -worn
to a properly oriented and configured electrode pad to controller device, the neck -worn controller comprising : an
achieve the desired relaxation effect by transdermal electri- elongate body configured to be worn on a user 's neck , an
cal stimulation of the neck (e . g ., and in some variations just 65 electrode -coupling region on the elongate body having at
at the neck ). In particular, the pair of electrical contacts may least one magnetic attachment configured to automatically
be separated by between 1. 2 inches and 0 .7 inches along the couple the first connector on the electrode pad to the a first
US 9, 956 , 405 B2
10
electrical contact on the neck -worn controller device when the electrode pad to form an electrical contact between the
the magnetic attachment is placed adjacent to the electrode neck -worn controller and the first electrode and second
pad , and a control circuitry , a power source and wireless electrode .
communication circuitry . Applying electrical energy may comprise applying TES
The first electrode and the second electrode may be 5 by delivering electrical energy between the first electrode
arranged in a line that on the first side that is at angle (e . g . and the second electrode , wherein the electrical energy
between 90° or perpendicular and 15 degrees, e.g . between comprises a carrier wave having a frequency that is greater
30 degrees and 60 degrees, etc .) to a line connecting the first
connector and the second connector electrically connected than is
250 Hz that is amplitude modulated at a frequency that
ten percent or less the frequency of the carrier wave ,
on the second side. further wherein the amplitude modulation is varied at least
The adhesive electrode pad (s ) may be configured to be once
worn on the back of a subject's neck so that the first 50 secevery , once
60 seconds ( e. g., once every 55 sec , once every
every 45 sec, once every 40 sec ., once every 35
electrode and the second electrode are arranged along a seconds, once every 30 seconds, etc .).
midline of the back of the user 's neck . In any may of the
be 1615 In general, the amplitude modulation may be varied in any
apparatuses and methods described herein , the pads may be
adhered to the neck -worn body before it is placed around theappropriate manner, including by varying the shape of an
user' s neck . Thus , the device may be used to place the pads envelope of the amplitude modulation . For example , the
onto the skin for the user . envelope shape may be changed between two or more of: a
In some variations , the applicants have found that it is square wave , a step -function , a saw tooth , a triangular shape,
particularly advantageous when applying TES energy to the 20 a sinusoid , etc . The amplitude modulation may be varied by
back of the user ' s neck to induce relaxation , to have one of varying one or both of a symmetry ratio and a flat ratio of
the electrodes (e . g ., the second electrode) be larger than the the amplitude modulation .
other electrode. For example , a surface area of one of the Applying TES to induce relaxation may include applying
electrodes may be greater than 1. 25 times the surface are of electrical energy for any appropriate length of time ( e . g ., for
the other electrode ( e. g ., greater than 1 .4x , greater than 1 .5x, 25 2 min or greater, 5 minutes or greater, 10 minutes or greater,
greater than 1 .6x, greater than 1 .7x, greater than 1 . 8x , 15 minutes or greater, etc .).
greater than 1 .9x , greater than 2x , etc . ). In general, applying may comprise delivering TES to a
In general, the neck -worn controller used as part of any of
nerve fiber , nerve or nerve bundle extending through the
the systems described herein may be any of the neck -worn user 's neck , including spinal nerve , cranial nerves , etc .
controllers described above . 30 For example, a method of applying transdermal electrical
For example , a system for applying transdermal electrical stimulation (TES ) to the back of a user 's neck to modify a
stimulation ( TES ) to the back of a subject' s neck to modify user 's cognitive state and induce a relaxed state may
a user 's cognitive state and induce a relaxed state may include : attaching a first electrode and second electrode to a
include: an adhesive electrode pad comprising a first elec - midline of a back of the user' s neck between the user' s
trode and second electrode arranged in a vertical line on a 35 hairline and the user 's C7 cervical region , wherein the first
first side, and a first connector electrically connected to the and second electrode form part of an electrode pad ; placing
first electrode and a second connector electrically connected a neck -worn controller over at least one of the user' s
to the second electrode, wherein the first and second con - shoulders and allowing the neck -worn controller to mag
nectors are arranged in a horizontal line perpendicular to the netically self- engage with the electrode pad to form an
vertical line on a second side that is opposite from the first 40 electrical contact between the neck -worn controller and the
side ; and a neck -worn controller device , the neck -worn first electrode and second electrode ; applying TES by deliv
controller comprising : an elongate body configured to be ering electrical energy between the first electrode and the
worn on a user ' s neck , an electrode -coupling region on the second electrode , wherein the electrical energy comprises a
elongate body having a magnetic attachment configured to carrier wave having a frequency that is greater than 250 Hz
automatically electrically and mechanically couple a pair of 45 that is amplitudemodulated at a frequency that is ten percent
electrical contacts on the electrode - coupling region with the or less the frequency of the carrier wave, further wherein the
first and second connectors on the electrode pad when the amplitude modulation is varied at least once every 60 ( e.g .,
magnetic attachment is within less than 1 inch from the 55 sec , 50 sec , 45 sec , 40 sec , 35 sec , 30 sec , etc .); and
electrode pad , a control circuitry, a power source, and a inducing, in the user, a relaxed mental by the application of
wireless communication circuitry 50 TES .
Also described herein are methods of applying transder - In general, any of the methods and apparatuses described
mal electrical stimulation (TES ) to the back of a user 's neck herein for self -engaging or attaching the electrode and the
to modify a user ' s cognitive state and induce a relaxed state . device may be configured to mechanically ( e . g ., loop -and
In general such a method may include : attaching a first hook , artificial setae , etc .), chemically ( e . g ., adhesive),mag
electrode and second electrode to a back of the user' s neck 55 netically , or otherwise ( including combinations of these )
between the user' s hairline and the user's C7 cervical attach . Alternatively, in some variations the apparatuses and
region ; applying electrical energy between the first electrode methods described herein are configured with the electrode
and the second electrode to deliver TES ; and inducing , in the affixed or attached ( including integrally attached ) to the rest
user, a relaxed mental by the application of TES . of the apparatus including the electrical contact (or electrical
Attaching may comprise adhesively attaching an elec - 60 support ).
trode pad comprising the first and second electrode to the
back of a user 's neck so that the first and second electrodes BRIEF DESCRIPTION OF THE DRAWINGS
are arranged along the midline of the user 's neck .
Any of these methods may also include placing a neck - The novel features of the invention are set forth with
worn controller around the neck of the user and allowing the 65 particularity in the claims that follow . A better understanding
neck -worn controller to self -engage (including magneti- of the features and advantages of the present invention will
cally, mechanically, chemically (e. g., adhesively ), etc.) with be obtained by reference to the following detailed descrip
US 9 ,956 ,405 B2
11
tion that sets forth illustrative embodiments, in which the controller include both flexible regions and rigid regions; the
principles of the invention are utilized, and the accompany region coupling to the electrode patch is rigid .
ing drawings of which : FIGS. 7A and 7B illustrate the electrode patch of FIG . 5
FIG . 1A is a schematic of a front (user- facing) side of an self-coupling (in this example, magnetically however, other
electrode pad ( e .g . patch ) or electrical contact that may be 5 techniques for self -coupling may be used , such as mechani
applied to a user 's skin or neck . The electrode patch may be cal, chemical, etc .) to the neck -worn controller of FIG . 6 . In
adhesive , and may include one or more (e .g . a pair of) FIG . 7 , the user has already applied the electrode patch to
electrodes formaking electrical contact with the user 's skin . the back of the neck so that a pair of self-connecting
The electrodes may be covered in a gel or other material to
connectors on the back of the electrode patch are oriented
enhance electrical contact. The electrode patch may include 10 horizontally , and the neck -worn controller is placed around
an adhesive ( e. g ., skin adhesive ) for securing the electrode the neck allowing
patch to the skin of the user 's neck . In any of these automatically align one and
of the self-connecting connectors to
connect with the first connector on
variations, the electrodes may include a single substrate or
the neck -worn controller
a plurality of substrates comprising multiple electrode/skin 15 connecting connectors connects . In FIG . 7B the second self
contact points . to the second connector.
FIG . 1B is a schematic of the back of an electrode patch Additionally , the patch or patches may be placed first onto
such as the one shown in FIG . 1A . In this example , a pair of the device and then the device /patch combination is placed
self- connecting connectors is included , which may make a together onto the back of the neck , allowing the device to
secure electrical connection to the neck -worn controller place the patch or patches .
( TES controller /stimulator ). The self -connecting connector 20 FIG . 8 shows a side perspective view of the neck -worn
in this example is a magnetic connector. Alternatively or controller such as the one shown in FIGS. 6 and 7A - 7B
additionally, the contact between the patch or patches and connected to an electrode patch on the back of a user 's neck .
the device may be self -adhesive via conductive gel contact . FIG . 9 shows another example of a neck -worn controller
FIG . 1C is an example of a neck -worn controller ( TES configured to connect to two ormore connectors (including
controller / stimulator ) that may couple to the electrical con - 25 self -connecting connectors such as magnetic connectors ) on
tact with one or more self - connecting connectors magnetic a n electrode patch . In this example , the neck -worn controller
connectors. In general the neck -worn controller may include may be rigid or semi-rigid ( e . g .,may include regions that are
electronics (controller, processor, etc .) for applying TES to less rigid , and / or may include hinged regions).
the electrodes of the electrode patch , a power supply pro - FIG . 10 illustrates the neck -worn controller of FIG . 9
viding power to the electronics , charging circuitry for the 30 coupled to an electrode pad ( e .g ., electrode patch ) on the
battery ( e .g ., inductive charging, plug -in charging , etc .), and back of a user ' s neck .
communications circuitry for communicating with one or FIG . 11 shows a front view of the neck -worn controller of
more remote processors thatmay be used to control/ regulate FIGS. 9 and 10 draped around the front of the user ' s neck .
the application of TES by the device . The neck -worn con FIG . 12 illustrates another example of a neck -worn con
troller may also include one or more controls for regulating 35 troller in which the neck -worn controller is configured to
the operation of the system ( e . g ., on / off, intensity up /down, extend around only one side of the user ' s neck .
etc . ). FIG . 13 illustrates one example of a self-connecting
FIG . 1D schematically illustrates a user electronics connector that may be included on either the neck -worn
device, such as a hand-held device having a processor that controller or the electrode patch and may form an electrical
may be wirelessly (or via a wired connection ) coupled to 40 connection between the two for applying TES from one of
neck -worn controller. The user electronics device may the electrodes of the electrode patch . The connector consists
include software , hardware , or firmware for operating the of a donut shaped magnet, and a ferromagnetic disc shown
system . in the center of the donut shaped magnet.
FIGS . 2A - 2D illustrate variations of electrode patches FIG . 14 illustrates another example of a neck -worn con
that may be used in any of the systems and methods 45 troller in which thebody of the neck -worn controller extend
described herein . FIGS . 2A - 2D all show the skin - facing, ing from the connector region (that connects to the electrode
front, side of the electrode patch , and include at least two patch ) is thin and flexible .
electrodes . FIG . 15 illustrates an example of a hinge region of a
FIGS. 3A - 3D illustrate variations of electrode patches neck -worn controller .
that may be used in any of the systems and methods 50 FIGS. 16A and 16B show an example of a neck -worn
described herein . FIGS. 3A - 3D illustrate the back side of the controller that is rigid or semi-rigid . FIG . 16A shows a back
electrode patch , which may self-connect or couple with the view perspective and FIG . 16B shows a front perspective
neck -worn controller. view .
FIGS. 4A and 4B schematically illustrate examples of FIGS. 17A - 17C illustrate another example of a neck -worn
neck -worn controllers . FIG . 4A shows a neck -worn control- 55 controller. FIG . 17A is a back perspective view , FIG . 17B is
ler that is worn on just one side of the user' s neck ( asym - a front perspective view and FIG . 17C is a top perspective
metrically ), coupling at one end region to the electrode view .
patch . FIG . 4B shows a neck -worn controller that is worn on FIGS. 18A - 18C show another example of a neck -worn
either side of the user' s neck (symmetrically ) coupling in a controller. FIG . 18A is a back perspective view , FIG . 18B is
middle region to an electrode patch . 60 a front perspective view and FIG . 18C is a top perspective
FIG . 5 illustrates one example of an electrode patch view .
coupled to the midline of the back of a user ' s neck so that FIG . 19 schematically illustrates operation of a system for
the first and second electrodes are oriented along the user's applying TES to induce a calm or relaxed metal state by
neck above the C7 region , but beneath the hairline ( e . g ., neuromodulation through a user 's neck region . In FIG . 19 ,
between the C1 and C7 regions of the spine ). 65 the system includes a neck -worn controller, an electrode
FIG . 6 shows one example of a neck -worn controller that patch and control software running on a user ' s hand -held
self-connects to an electrode patch . In FIG . 6 the neck -worn electronic device (shown in this example as a smartphone).
US 9 ,956 ,405 B2
13 14
FIG . 20 illustrates characteristics of a carrier wave that shown in FIGS. 30A -31 , the cartridge may rehydrate the
may be used to apply TES neuromodulation a described reusable electrode pads. FIGS. 33A and 33B show back and
herein . front perspective views, respectively, of the storage /recharg
FIGS . 21A and 21B generally illustrate the variable ing chamber configured as a stand with the chamber opened
amplitude modulation of a carrier wave to induce a calm or 5 and the neck -worn TES controller / stimulator held therein .
relaxed mental state when applied at the user 's neck region FIGS. 34A and 34B illustrate the storage /recharging
as described herein . chamber of FIGS. 33A and 33B with the chamber closed
FIG . 22 illustrates variable parameters that may be modi- over the reusable electrodes of the neck -worn TES control
fied by the variable amplitude modulation methods ler/stimulator . FIG . 34A is a back perspective view and FIG .
described herein . 10 34B is a front perspective view .
FIG . 23 illustrates one example of a TES waveform FIG . 35 illustrates an example of subject ( user ) wearing a
showing changes in the carrier wave (frequency , peak cur - neck -worn TES controller/stimulator.
rent, % duty cycle, % DC ) and changes in the amplitude FIGS. 36A - 36D illustrate another example of a neck
modulation ( AM duty cycle , AM frequency , AM flat ratio worn TES controller stimulator as described herein . FIG .
( % ), AM symmetry ratio ( % ), and AM DC offset ( % )). This 15 36A shows a right side view , FIG . 36B shows a front
waveform is an example of a relaxation -inducing waveform perspective view , FIG . 36C shows a back perspective view ,
as described herein . and FIG . 36D shows a back view .
FIGS. 24A - 24D illustrate another example of a neck FIG . 37A - 37C illustrate locations for electrode placement
worn controller (e . g ., TES controller/stimulator) that is rigid of a neck -work TES controller/stimulator as described
or semi-rigid , including attachment sites for electrodes . FIG . 20 herein . The electrodes may be separated by an approxi
24A is a back view ; FIG . 24B shows an enlarged front view mately 1 inch minimum distance and arranged in an anterior
of the electrode attachment sites ; FIG . 24C is a front view ; to posterior (e . g . foot to head ) longitudinal direction , so that
and FIG . 24D is a side perspective view . the electrodes are stacked atop each other relative in the
FIGS. 25A and 25B illustrate another example of a longitudinal axis . For example , in FIG . 37A , the first ( upper )
neck -worn controller that is rigid or semi-rigid . FIG . 25A is 25 electrode is on the skin over the C1 to C6 regions of the
a front perspective view , and FIG . 25B is a back view . spine, and the second ( lower ) electrode is over the C2 to C7
FIGS. 26A - 26D illustrates a prototype of a neck -worn region of the spine. In FIG . 37B the first (upper ) electrode
TES controller /stimulator as described herein , similar to the is in the cervical region of the spine, while the second
variation shown in FIGS. 1C , 16A - 18C , and 24A - 25B . In (lower ) electrode is over the thoracic region (e . g ., T1 or T2
this example , the electrodes are shown connected by a wire , 30 region ) of the spine. In FIG . 37C the distance between the
e . g ., for connection to a user- held /remote electronic device upper and lower electrodes has been increased, but the first
which may include some or all of the control circuitry ; this ( upper ) electrode is still in the cervical region while the
wire connection may be replaced with a wireless connection . second ( lower) electrode is over the thoracic region .
FIG . 26A shows a back perspective view ; FIG . 26B shows FIG . 38A shows an example of an adhesive electrode pad
a top view , FIG . 26C is a back view , and FIG . 26D is another 35 configured to be worn over the cervical and thoracic region
back perspective view . (similar to that shown in FIG . 37B ) having a pair of snaps
FIGS. 27A -27C illustrate an example of a neck -worn TES to which a TES controller /stimulator may be coupled . The
controller/stimulator having integrated electrodes that may adhesive electrode pad may be configured as an adapter to
be configured as self-cleaning and self -rewetting electrodes. adapt a forehead/temple TES controller /stimulator apparatus
FIG . 27A is a front perspective view and FIG . 27B is a back 40 for use on the neck as described herein .
perspective view of the apparatus. FIG . 27C is a top per - FIG . 38B shows adhesive electrode (adapter ) of FIG . 38A
spective view with the reusable /rewettable and/ or self -clean - with a TES controller/stimulator coupled thereto .
ing electrodes in a closed configuration . FIGS. 39A - 39B show front and back views, respectively
FIG . 28 is a back perspective view of a neck -worn TES of a controller device for applying transdermal electrical
controller /stimulator such as the one shown in FIGS. 27A - 45 stimulation ( TES ) to modify a user 's cognitive state and
27C without the reusable electrode contacts. induce a relaxed state, such as the device shown attached to
FIG . 29 is a schematic illustration of an example through the electrode pad adapter in FIG . 38B .
the self- cleaning and self- rewetting electrodes in an elec - FIGS. 40A -40F illustrate an example of a top cover
trode storage /recharging chamber. portion of a controller/ stimulator TES apparatus such as the
FIGS. 30A -30C illustrate a neck -worn TES controller / 50 one shown in FIGS. 39 A - 39B . FIG . 40A is a front view . FIG .
stimulator such as the one shown in FIGS. 27A - 27C within 40B is a back view , showing the inside region of the top
an electrode storage /recharging chamber (or cartridge ) such . cover. FIG . 40C is a bottom side view along a long side of
FIG . 30A is a top perspective view with the storage /recharg - the device . FIG . 40D is a second side view . FIG . 40E is a
ing chamber opened ; and FIGS. 30B - 30C are alternative top view through a partial section taken through line A - A of
perspective views with the storage / recharging chamber 55 FIG . 40B . FIG . 40F is a front perspective view .Note that the
closed . dimensions shown, as for all dimensions shown throughout,
FIG . 31 is a schematic view of the storage /cleaning are exemplary (unless otherwise indicated ), and may be
chamber over a neck -worn TES controller / stimulator such as approximate . These dimensions are shown in millimeters
the one shown in FIGS. 27A - 27C . (mm ).
FIG . 32 is an example of a self-re -wetting electrode that 60 FIG . 41A -411 illustrate an example of a bottom cover
may be used in any of the apparatuses described herein , portion of the controller/stimulator TES apparatus such as
including in particular the neck -worn TES controller/ stimu- the one shown in FIGS. 39A - 39B . FIG . 41A is a front view ,
lators . showing the internal region of the bottom cover. FIG . 41B
FIGS. 33A and 33B show an example of a clam shell is a back view , showing the outer surface . FIG . 41C is a
cartridge that is also a stand thatmay be used with any of the 65 bottom side view . FIG . 41D is a sectional view through line
apparatuses (e . g ., the neck -worn TES controller/ stimulators ) T - T in FIG . 41A . FIG . 41E is an enlarged view of the port
described herein . Similar to the storage/recharging chamber (e.g., micro USB port) opening visible in FIG . 41B . FIG .
US 9, 956 , 405 B2
15 16
41F is a sectional view through line A - A in FIG . 41A . FIG . a user's cognitive state and induce a relaxed state is illus
416 is a sectional view through line R - R in FIG . 41A . FIG . trated in FIGS. 1A - 1D . In this example, FIGS. 1A and 1B
41H shows an enlarged view of the button region of the illustrate one example of an electrode patch (which may also
apparatus. FIG . 411 shows a sectional view through line B - B or alternatively be referred to as an electrode strip , pad ,
in FIG . 41A . Asmentioned above, the dimensions shown are 5 electrode pad , contact strip , or the like ). The electrode patch
in mm and are exemplary and may be approximate , unless is configured and may be specifically adapted to be worn and
otherwise indicated . easily applied to the back of the user ' s neck . In particular,
FIGS. 42A -42C show front, back and side views, respec - the electrode patch may be configured so that it can be
tively, of an example of an adapter (neck -only ) electrode applied by user themselves without requiring a mirror or
pad . 10 other tool, or without the intervention of a third party . For
FIG . 43A shows a bottom ( skin - contacting ) view of an example the electrode body 105 may be shaped to enhance
example of a portion of an adapter electrode pad that is placement. The body 105 may be a thin (e . g ., flat, generally
configured to be applied to the subject' s neck so that a pair planar , somewhat flexible ) layered material. In FIG . 1A the
of TES electrode pads can be positioned over the cervical schematic shows the body 105 as having an oval shape. In
and/or thoracic region of the spine. These adapter electrode 15 some variations it may be desirable to have a shape that is
pads may be referred to as adapters , adapter pads or adapter elongate that indicates the center region so that may be
electrode pads because they may adapt a forehead or temple placed in /near the midline of the neck . For example , the
controller /stimulator TES apparatus, such as the one shown body may be shaped in an hourglass or waisted shape (e.g .
in FIGS. 40A -411, above , to apply TES to the neck (and a lobed shape, such as a bi- lobed shape).
particularly the C4 -T2 region ) only . They may also be 20 As shown in FIG . 1A , the electrodes that are configured
referred to as neck -only electrode pads . In FIG . 43A a view to contact the user' s skin 107 , 109 are arranged vertically in
of the bottom (skin -contacting side) is shown . FIG . 43B the electrode patch , so that they may be applied in a line
shows the top view of the connector portion of the adapter along the midline of the neck ( e . g ., where the midline of the
of FIG . 43A . FIGS . 43C -43F illustrate layers the may be back of the neck extends down from the top of the head
formed to make the apparatus of FIG . 43A . For example , 25 along the spine near a central region of the neck ) . One of the
FIG . 43C shows the conductive trace (silver ) applied to the electrode is preferably larger (e . g ., has a larger surface area )
device ; FIG . 43D shows the carbon back layer; FIG . 43E than the other. For example , the lower electrode 109 in FIG .
shows a bottom view of the dielectric layer; and FIG . 43F 1A is smaller than the upper electrode ( in some variations
shows a top view of the dielectric layer. the lower electrode is smaller than the upper electrode ). In
FIGS. 44A - 44B show front and side views, respectively , 30 this example , the electrodes are approximately rectangular ,
of an adapter electrode pad having a connector and coupling although they may have other shapes , including oval, cir
region such as is shown in FIGS. 43A -43F , above , also cular, or irregular. In this example, the electrodes include
including the electrode pads for the first ( upper ) and second silver- coated , conductive contacts that are separated by
(lower ) electrode. FIG . 44C shows an exploded view of the about 1 inch 0 .7 inches center to center ( e .g ., 1. 2 to 0 .6
first (upper ) connector pad portion . FIG . 44D shows the 35 inches , 1. 1 to 0 .65 inches, 1. 0 to 1 . 7 inches, 1 . 0 to 0 . 8 inches ,
potential dimensions of the first (upper ) connector pad etc .). The first electrode 107 is approximately 0 . 95 inches by
portion . FIG . 44E shows an exploded view of the second 1 inch and the lower ( second ) electrode 109 is approxi
(lower ) electrode pad portion . FIG . 44F is an example of the mately 1 . 24 inches by 2 inches. Surprisingly, the Applicants
foam portion of the second (lower ) electrode pad . FIG . 44G have found that having electrode pairs in which the elec
illustrates potential dimensions for other layers of the appa - 40 trodes are different surface areas gives better effects .
ratus that may be included as part of the neck -worn appa - FIG . 1B shows an example of the back of the electrode
ratus. The dimensions shown in these figures are exemplary patch shown in FIG . 1A . In this example , a first connector
(and may be approximate ) and are in inches. 111 is electrically connected through the body 105 to the first
FIG . 45A is a front view of an assembled adapter elec - electrode 107 and the second connector 113 is electrically
trode pad as described herein . 45 connected through the body 105 to the second electrode 109 .
FIG . 45B is a side view . FIG . 45C illustrates the formation The first and second connectors are configured to make
of the adapter electrode pads on and as part of a roll. electrical contact with electrical contacts on the neck -worn
FIG . 46 illustrates a packaging (pouch ) for an adapter controller ( see , e. g ., FIG . 1C ). FIG . 13 shows one example
electrode pad such as the ones shown in FIGS. 42A - 45B . of a connector that may be used . This connector is electri
50 cally conductive and also in this embodiment ) is configured
DETAILED DESCRIPTION to self- connect to the neck -worn controller by virtue of
forming a magnetic connection with the electrode -coupling
In general, described herein are apparatuses and methods region on the neck -worn controller. For example , in some
for applying transdermal electrical stimulation (TES ) to the variations the connector may be a ferrous or magnetic
back of a subject' s neck to modify a user' s cognitive state 55 material or any other material that is strongly attracted to
and induce a relaxed state. In particular,described herein are magnetic attachment on the electrode-coupling region of the
electrode patches and neck -worn controllers that are adapted neck -worn controller.
to deliver TES to a specific and particularly effective region For example , the neck -worn controller shown in FIG . 1C
of a patient's neck (and in some variations only this region ) is configured as a U -shaped , semi-rigid body 121 . The arms
at or near the midline of the back of the neck between /over 60 of the body may be worn on either side of the user ' s neck
the C1 and C7 regions of the spine, beneath the hairline . and may include (e . g ., house ) or be connected to the
Stimulation with the apparatuses and parameters described controller circuitry , processor, memory , signal generator,
herein outside of this region , and with other parameters than etc ., and /or power supply ( e. g ., battery , etc .) and/ or wireless
those descried herein , are less effective or may be ineffec - communications circuitry . In some variations the circuitry
tive, and in some variations may induce contrary effects . 65 and /or power supply may be distributed between the end
A generic system for applying transdermal electrical regions 151, 161 of the body 121 so that the weight and /or
stimulation ( TES) to the back of a subject's neck to modify shape is balanced . The electrode coupling region 131 in this
US 9 ,956 ,405 B2
17 18
example is located centrally to be worn around the back of shown ), battery and wireless communication circuitry may
the user 's neck . In some variations the electrode coupling be located within the elongate body and/or at the distal end
region may be rigid . region 433. The example shown in FIG . 4B also includes a
Asmentioned , the electrode coupling region is configured flexible elongate body 405', but is configured to wrap around
to automatically connect ( in a proper orientation ) and secure 5 both sides of the user ' s neck when worn . The electrode
to the connector on an electrode patch worn on a user. In coupling region 421' is in a central region .
some variations the electrode coupling region may include In general, the apparatus is configured so that the elec
one ormoremagnets (electromagnets, permanentmagnetics trode patch is applied beneath the user 's hairline , in the
such as neodymium iron boron (NdFeB ), samarium cobalt cervical region of the back of the neck ( e . g ., down to
(SmCo ) , alnico , and ceramic or ferrite magnets , etc .) . Alter - 10 approximately C7 spinal region ). This midline location and
natively or additionally , the attachment may be a mechanical spinal levelmay help the TES applied as described herein in
attachment such as a snap , etc . that forms the electrical correctly activating and /or inhibiting nerves under the elec
connection . The attachment may be a hybrid electrical and trode patch and may improve parasympathetic drive and
mechanical attachment, such as an electrically conductive inhibit sympathetic drive at this cervical region . The elec
hook -and -latch (e . g ., " conductive VELCRO " ) material. The 15 trode pair is generally placed behind the neck , so that the top
self- connecting attachment may be integrated with or sepa - electrode is close to the hairline around the center (midline )
rate from the electrical connection . Alternatively or addi- of the spine . The second electrode is about an inch ( e. g .,
tionally, the attachment and /or connection may be physical between 0 .6 and 1.3 inches , 0 .7 and 1.2 inches , 0 . 8 and 1.2
and self -adhesive by employing conductive and adhesive inches, etc .) below the first electrode. The two electrodes
materials to the patches like a hydrogel, hydrocolloid and the 20 may be connected to the connectors. In some variations the
like. connectors are iron , steel, or other material that may be
FIG . ID illustrates an electronic device 171 (e.g., a magnetically attracted and held . These connectors may be
hand -held or wearable electronics device such as a smart snaps that can make an electrical and /ormechanical con
phone , pad , smartwatch , etc .) that may be used along with nection . In some examples they may be placed on the left
the electrode patch and the neck -worn controller device. The 25 and right sides of the neck .
electronic device may wirelessly communicate with the FIG . 5 shows an example in which steel snaps are placed
neck -worn controller and may be used to control any of the on the left and right side of the back of the neck when the
operations of the controller including: turning on /off the electrode patch is worn on the back of the neck . In this
device , starting/stopping delivery of TES waveforms, paus - example the electrode patch 501 includes an adhesive for
ing delivery of TES waveforms, user - control or modulation 30 holding it to in contact with the skin . The self - connecting
of the TES waveforms, user control or modulation of the connectors 503 are steel snaps that can be magnetically
intensity of TES applied ( e . g ., current amplitude , frequency , attracted , held and form an electrical connection to the
etc . ), selecting which TES waveform to apply from a library electrodes on the inner side of the electrode patch (not
of waveforms, tracking/ logging use/ operation of the appa - visible ).
ratus , checking and reporting status of the apparatus , locking 35 As illustrated in the example shown in FIG . 6 , a neck
( e. g ., parental lock , user lock , etc .) the apparatus use (secu - worn controller 601 may include one or more magnets 603 ,
rity ) , etc . 603' that are affixed to the elongate body 605 of the device .
FIGS. 2A - 2D , similar to what is shown in FIG . 1A , In this example, the electronics for generating and delivering
illustrate variations of electrode positions and shapes that the TES to the electrodes when the electrode patch is
may be used on the patient-facing (skin facing ) side of the 40 connected may be held at the end(s ) of the elongate body
electrode patch . In FIG . 2A the electrodes are shown as 609 , which in this example is a flexible (e . g ., fabric ) mem
equal size surface areas , while in FIG . 2B the surface area ber.
of the upper electrode is > 1. 3x the surface area of the lower In operation , as shown in FIG . 7A , the magnets in the
electrode . In FIG . 2C the electrodes are arranged horizon - neck -worn controller may be attracted to the steep snaps
tally rather than vertically, while in FIG . 2D the electrodes 45 even if they are initially a distance (e . g ., up to 1 inch in some
are arranged concentrically. variations , generally less than 1 .2 inches , 1. 2 inches, 1 .0
Similarly, FIGS. 3A - 3D illustrate the configuration of inches, 0 . 9 inches , 0 . 8 inches , etc . away ). As shown in FIG .
various connectors that may be used to make electrical 7B , once connected , the neck -worn controller may rest
and / or mechanical connection . For example , in FIG . 3A the comfortably behind the user ' s neck . In the example shown
back of the electrode patch includes two electrical connec - 50 in FIGS. 7A - 7B , the elongate body of the neck -worn con
tors 331, 332 that may make electrical and/ or mechanical troller is an elastic band .
contact with the electrodes on the front, and an outer As shown in FIG . 8 , the ends of neck -worn controller may
magnetic contact 335 at least partially surrounds them , include one more controls (buttons, switches , dials , etc .) 809
extending at the periphery of the body of the electrode patch . for control of the operation either separately or in addition
Thus, the magnetic contact 335 may mate with a magnet on 55 to wireless control using an electronics device . The elec
the electrode coupling region . tronics device may be a dedicated device ( e . g ., hardware
FIG . 3B shows another variation with a pair of electrical and /or software and /or firmware ) for wirelessly controlling
connectors 331 , 332 and a magnetic contact 335 ' in the operation of the device, or it may be a user -provided devices
middle . FIGS. 3C and 3D show other variations in which the such as a smartphone, pad or wearable electronics ( e. g .,
connectors may be hybrid connectors ( e . g ., that act both to 60 smartwatch , etc .) running software ( e . g . an application soft
magnetically or otherwise attract/connect to the electrode ware ) or communicating with a remote server to control
coupling region of the neck -worn controller ). operation of the neck worn applicator and therefore TES
FIGS. 4A and 4B illustrate variations of neck -worn con application . In FIG . 8 , placing the buttons in the front near
trollers . In FIG . 4A the elongate body 405 is pliable or the end (s ) may make them easy to access by the user .
flexible. A rigid electrode coupling region 421 is located at 65 FIG . 9 is another example of a neck -worn controller
one end and may self - connect to an electrode patch on the device . In FIG . 9 the device body may be rigid or semi- rigid ,
user ' s neck . The controller electronics (circuitry , not and is shown as U -shaped . The body may be pulled open to
US 9 ,956 ,405 B2
19 20
apply onto the user' s neck . In this example a pair ofmagnets box 1907 ). The controller generates and applies the TES
901 may be used to magnetically self -connect (and align and waveform . The controller may be directly connected to the
secure ) the neck -worn controller to an electrode patch on the electrodes (via physical connection , e . g ., wire , lead , etc .) or
user ' s neck , as shown in FIG . 10 . The device may include via a wireless connection . In general, these TES waveforms
the control electronics inside of the elongate body , which 5 may include a relatively high frequency carrier wave ( e. g .,
may include a housing 909 for holding them . > 250 Hz, greater than 1 kHz, greater than 2 .5 kHz, greater
Any of the variations described herein could also include than 5 kHz, greater than 7 kHz, greater than 9 kHz, greater
an output ( e . g ., LED ) showing status of the device as it than 10 kHz, etc ., between 250 Hz -50 kHz, between 250
operates, and/ or the operational state of the device . In some Hz- 35 kHz, etc.). One or more parameters of the carrier
variations the apparatus includes speakers ( e. g ., ear buds that 10 waves may be varied or modulated , including one or more
may be worn in the ears ) and may also be configured to play of: current, frequency , duty cycle, percent ( % ) DC , pulse
music or other audio content. For example , in any of the number and shape, and /or burst frequency . Alternatively and
apparatuses and methods described herein , the neck -worn
controller may include a radio , music player, and /or may surprisingly , these parameters may be kept relatively stable
wireless communicate with a music or other source of audio 15 modulated , andTES
throughout the and the TES signal may be amplitude
particularly may be variably amplitude
(CD player, digital music player, radio , etc . including a
phone ). The audio content (music . ambient noise, etc .) may modulated , in which one or more parameters of the ampli
be synchronized or otherwise coordinated with the applied tude modulation (which typically has a lower frequency by
TES waveforms. In some variations the music (tempo , approximately 1/ 10th of the carrier wave frequency or less
changes/ transitions in tempo , etc.) could trigger ormodulate 20 (e .g., less than 1 kHz, 950 Hz, 900 Hz, 850 Hz, 800 Hz, 750
the TES waveform parameters ( including one or more of the Hz, etc .) . During operation , the one ormore AM parameters
parameters of AM as described in FIGS. 21A - 23 , below ) . are varied during every 30 seconds or faster ( e . g ., < 30
Any of these variations may also or additionally include seconds, < 25 seconds, < 20 seconds, < 15 seconds, < 10
a charging or other input/output port, such as a mircoUSB seconds, etc .).
port. Alternatively or additionally the devices may include 25 In the example of FIG . 19 , the electrode -driving controller
an inductive charging circuit or any other appropriate charg - 1907 may coordinate the activity of the voltage/current
ing apparatus. source ( e.g ., battery , voltage and/or current regulating cir
FIG . 12 is another example , similar to that shown in FIG . cuitry ) , clocks , and other circuitry to deliver waveforms (or
4A , in which the device is configured to be worn on one side an ensemble of waveforms) to the electrodes . The local
of the user 's neck , when self -attached to the electrode patch . 30 controller 1907 connected to the electrodes may also regu
In this variation the neck -worn controller drapes over the late the electrodes themselves ( e . g ., monitoring and adjust
user ' s neck on one side , so that the magnets 1207, 1208 are ing the wetness of the electrodes , as described herein ). The
attached behind the neck to connecting electrodes on the local controller may also receive input from a remote
electrode patch , and the internal electronics are located at the controller, including user-held device (e .g ., handheld user
opposite end 1205 . 35 electronics device such as a smartphone, wearable electron
The exemplary neck -worn connector shown in FIG . 14 is ics , etc .) 1913 . The user -held device may send commands
very thin and is configured as a wire that may include one (start/ stop, intensity control information , waveform param
or more ( e. g ., two ) rigid regions at the electrode -coupling eters , etc .) to the local controller 1907. In FIG . 19 this
region for connecting to the connectors on the electrode communication is shown to be wireless 1909. For example ,
patch . In some variations, as shown in FIG . 15 , the neck - 40 a user may operate a smartphone or other user -held device
worn controller device may include a hinge 1501 or more (tablet, pad , laptop , etc .) to control operation of the local
flexible region that will allow the device to be taken on /off controller 1907. The user -held device may run software
the user 's neck even when the body is generally more rigid . ( such as an application software ) including a user interface .
FIGS. 16A and 16B illustrate an example of another In some variations a separate user - held device is not used ,
variation of a neck -worn controller device having a gener - 45 and the local controller may integrate all or some of the
ally U -shape . FIGS. 17A - 17C show another variation with a features of the user- held device .
slightly different form factor. Finally , FIGS. 18A - 18C show Amplitude modulation typically applies an envelope (e.g.,
another variation having a rigid or semi-rigid elongate body bursting ) at a lower frequency that modulates the peak
that is generally U - shaped , an electrode-coupling region amplitude of the carrier wave forming the waveform . Tran
near the middle of the body , and wherein the body holds the 50 sitions in the TES waveforms may include changes in
power source (e . g ., large -capacity capacitor, rechargeable frequency , amplitude , duty cycle , etc ., as shown in FIG .
battery , etc .), control circuitry and wireless communication 21A ; alternatively or additionally , the changes in TES wave
circuitry . forms may be transitions incorporated by the apparatus in
Signal Modulation the amplitude modulation characteristics. See, for example ,
As described above , any of the devices described herein 55 FIG . 22 .
are configured to apply transdermal electrical stimulation to FIG . 22 graphically illustrates the amplitude modulation
achieve neuromodulation (e . g., through the back of the (AM ) of a carrier frequency , showing two complete periods
neck ). Both the TES application location at the midline of of the amplitude modulation . In general, the amplitude
the back of the user 's neck and the waveforms applied modulation may have bursting, resulting in a periods where
(“ TES waveforms” ) have been optimized to induce a relaxed 60 the envelope results in no signal ( 0 amplitude ), or it may
mental state . switch the polarity of the signal (as shown in FIG . 22 ). FIG .
For example , FIG . 19 schematically illustrates the opera - 22 also graphically illustrates the symmetry ratio of the AM ,
tion of a system as described herein . In this example, a pair in which the symmetry ratio is the percent of the total area
of electrodes (which may be an electrode patch 1905 or to the AM signal to the left of the midline 2201 of the period
separate electrode patches ) are connected to a user 's neck , 65 divided by the total area of the period of the AM signal. In
including in some variations (but not necessary ) via a neck FIG . 22 , the Symmetry ration is 50 (50 % ). The flat ratio is
worn controller or other controller (shown schematically by also illustrated , and is the percent of the duration of a single
US 9 ,956 ,405 B2
21 22
period in which the AM signal stays at peak (e .g., in FIG . 22 when applied between an electrode on the midline of the
the Flat ratio is approximately 20 , or 20 % ) . neck (between the C1-C7 region ) and an electrode on the
An example of the compound waveform (ensemble wave - forehead .
form ) for use with any of the methods and apparatuses
descried herein is shown in the table in FIG . 23 . In this 5 EXAMPLES
example, each parameter is held in a particular value for the
time period indicated ; the cognitive effect of relaxation may FIGS. 24A -242D illustrate another example of a neck
result because of the transitions between these parameter worn TES apparatus that includes a pair of electrodes (or
values . For example , in FIG . 23, the apparatus initially starts connectors to couple to electrodes ) configured to contact the
from an " off " setting (0 values for all parameters ) and 10 midline of the back of a user ' s neck . Although many of the
increases to the values shown in the first column ( e . g ., examples shows and discussed above include a magnetic
during the first 15 seconds ). Thereafter , they are held for 45 attachment between the electrodes, such as electrode patches
seconds, then the carrier frequency is shifted only very that include an adhesive and / or a conductive gel, any of the
slightly ( if at all) , while the frequency of the AM modulation apparatuses described herein that use an electrode may be
is cut in half , from 800 Hz to 400 Hz, after another 25 15 configured to instead of additional use a dry electrode
seconds, this is switched back to 800 Hz, and so on . This (without a conducive gel), a self -wetting electrode, a self
variable AM results in a profound user experience of relax cleaning electrode and / or an integrated electrode that does
ation . not removably couple to an electrical contact.
Thus, by creating transitions in the flat ratio , symmetry FIG . 24A shows the back of a neck -worn TES apparatus
ratio and DC offset in the amplitude modulation , the appa - 20 2400. This exemplary apparatus is a semi-rigid torc (having
ratus may greatly enhance the efficacy of the TMS waveform a u -shaped body ) that is configured to be worn around the
applied in evoking a relaxed cognitive state. For example, user' s neck . In this example the pair of electrodes 2405 ,
during the application of a TMS waveform , the amplitude 2407 extend perpendicular to the long, curving axis of the
modulation maybe transitioned (e.g ., every 1- 30 seconds) torc body 2411. Each electrode 2405 , 2407 is connected to
from a square shape to a saw tooth to a trapezoid shape; the 25 the torc body through an electrical contact. In this example ,
carrier wave may have an amplitude from between 1 -30 mA , a pair of electrical contacts are arranged adjacent to each
a frequency of between 250 Hz and 50 kHz, be biphasic (and other and separated by between 5 mm and 60 mm apart
in some variations asymmetric ), similar to what is shown in (approximately 40 mm in this example , center -to -center ) .
FIG . 20 . The electrical contacts are positioned in the middle region of
In general, a TES carrier waveform such as shown in FIG . 30 the torc body, and form an electrode -coupling region , where
20 may be defined by a duration , direction , peak current, and the electrode couples to the user ' s neck . The electrical
frequency . In some embodiments , a TES carrier waveform is contact supports and backs the skin -contacting electrode . As
further defined by a percent duty cycle (FIG . 20 ), percent mentioned , in some variation the skin -contacting electrode
direct current (FIG . 20 ), ramping or other amplitude modu may be removably coupled to the electrical contact (includ
lation , one or multiple frequency components , phase rela - 35 ing self- coupling, such as magnetically coupling ), and /or it
tionship of biphasic current, flat or structured noise , wave may be integrated on the electrical support. In FIG . 24 , the
shapes ( i. e. saw tooth , triangular, sine wave , square wave , electrodes are shown as reusable " dry ” electrodes ( e . g ., not
exponential, or other wave shape), capacitance compensa - including a gel); in some variations they may be self-wetting
tion features , or other parameters . As used herein , ' percent electrodes /re -wettable electrodes as will be described in
duty cycle ' may refer to the proportion of a cycle of a 40 greater detail below .
waveform that causes non -zero (or nominally non - zero ) The neck -worn TES apparatus may also include one or
current to be delivered transdermally (see equation , FIG . more indicator lights 2409 , such as LEDS that may indicate
20 ). Further, “percent direct current may refer to the non - operation of the device . The ends of the neck -worn device (s )
zero portion of a waveform cycle that is positive- going (see (e.g ., first end 2413 and second end 2415 ) may hold someof
equation, FIG . 20 ). 45 the electronics ( e . g ., controller , battery , antenna , etc.) . Any
In some variations , amplitude modulation below 100 Hz of these devices may also include one or more speakers ,
may be particularly effective , including amplitude modula - headset ( e . g ., earbuds , etc .) or the like , and may include a
tion at frequencies as low as 10 Hz ( e . g ., between 10 Hz and tuner ( e . g ., for connecting to commercial radio or wireless
100 Hz ); this AM frequency when used to modulate a carrier radio to play audio content) and /or memory ( e .g . for playing
wave as described herein in regions other than the midline 50 stored audio files , including digital audio content) .
of the back of the neck is not typically effective to induce FIG . 24B shows an enlarged view of the electrode
relaxation . For example , amplitude modulation frequency as coupling region near middle region of torc body between the
low as or lower than 100 Hz when applied to the neck and first and second ends. The electrode - coupling region typi
temple region are not effective , often causing pain and cally couples the electrodes to the user 's ( the person wearing
disturbing flashes of light. 55 the apparatus) neck . In FIG . 24B the electrodes 2405 , 2407
Also described herein are TMS waveforms in which the are visible and are shown connected to the electrical contacts
polarity of the electrodes (anode and cathode ) may be that support them 2415 , 2417 . The electrodes in this example
switched during the TMS application by the neck -worn are integrated onto the electrical contacts ( shown here as
controller. electrode supports 2415 , 2417 ). Any of these apparatuses
Although the apparatuses and methods described herein 60 may also include a region or portion 2422 that may include
are primarily for use in inducing relaxation ( calm ) by one or more sensors ( e . g ., skin sensors , sensors detecting
applying particular subsets of TES to just the region in the contact/wetness of the electrodes, etc .), adhesive , and /or
back of the user ' s neck , these methods and apparatuses may m ay house any of the circuitry and /or fluid storage reservoirs
be modified for use with additional electrodes on other body for use in rewetting electrodes.
regions , including the temple ; interestingly, the inventors 65 Aswill be described below in reference to FIGS. 25A and
have found that a feeling of euphoria may be induced when 25B , the electrode supports may be biased so that they hold
stimulating with some of the waveforms described herein the electrodes against the user ' s neck when the torc is worn .
US 9, 956 , 405 B2
23 24
For example , the electrode supports may include an arm or configured as part of a more durable cartridge that needs less
arms that is angled or biased inwards ( e .g ., towards the neck , frequent replacement . A gel body may or may not be
when worn ). The weight of the torc may help hold the adhesive . If the gel is not adhesive , a secondary material or
electrodes against the user's neck . In some variations the structure (e .g ., bias ) may provide or maintain the contact
ends of the apparatus body may be weighted ( e . g ., may 5 with the users skin . In any of these variations a reusable
weigh more than 5 grams, more than 10 grams,more than 15 electrode pad , that may be removed from the body and
grams, more than 20 grams, more than 25 grams, more than reapplied later , may include multiple sacrificial adhesive
30 grams, more than 35 grams, more than 40 grams, etc .), layers . For example , a secondary material may be a single
each . The electrode supports may be configured as a spring layer or a plurality of layers, whereby removing one exposes
arm ( e. g ., leaf spring, etc .), or may include a bias ( e .g ., 10 fresh layers of underlying materials.
spring ) element. In any of the variations described herein , the device
FIGS. 24C and 24D illustrate the overall apparatus shown contacts ( e . g ., electrodes ) may be configured to move inde
in FIGS. 24A and 24B . The torc body is semirigid , and may pendent of each other. For example , and upper electrode (or
be worn around the neck pulling apart the ends slightly to fit electrode patch ) may be adhered to the user ; as the user
it over the neck , then pacing it so that middle back region of 15 moves their head , the upper electrode may travels with the
the apparatus (the electrode -coupling region ) may hold the head differently from the lower electrode, which is attached
electrodes (arranged above and below the long axis of the to a separate part of the head . Alternatively or additionally ,
torc ) coupled against the users bare neck skin . As men - the material geometry and / or durometer may allow the
tioned , an adhesive material on the electrodes or adjacent electrode patch to differentially contact and expand over its
region ( s) 2422 may help secure it in place . In the Example 20 width and length , allowing the different electrodes to move
shown in FIGS. 24A - 24D the electrodes are illustrated as independent of each other and with the users ' movements .
somewhat small; larger electrodes may be used for one (e . g ., Reusable Electrodes
anode or cathode ) or both (anode and cathode) electrodes. Any of the neck -worn TES apparatuses described herein
The example device shown in FIGS . 25A and 25B is may include reusable electrodes that are configured to be
similar to that illustrated above in FIGS . 24A - 24D , however 25 automatically cleaned ( e.g ., when inserting into a holder or
the electrode supports in this example extend from the torc cartridge , as described herein ) and / or self - re -wetting elec
body on electrode support arms 2505 , 2507 that may help trodes. FIGS . 27A - 27C , 28 , 29 , 30A - 30C , 31 , 33A - 33B and
hold the electrodes against a user 's neck in the desired 34A - 34B all illustrate example of self re -wetting electrodes
positions. incorporated as part of a neck -worn TES apparatus.
FIGS . 26A - 26D illustrate an early prototype device con - 30 In general, it may be desirable for any of the apparatuses
figured for use with a pair of adhesive electrode patches described herein to be " dry ” electrodes. A dry electrode
2615 , 2616 . These electrodes couple to a controller (not becomes conductive when moistened , e .g ., with droplets of
shown ) via a cable or cord 2607 . The electrodes may be saline solution . Dry electrodes may be easier to store and
coupled to electrode contacts forming part of each electrode use , and may be used without leaving adhesive residue on
support 2609. FIG . 26C shows a back view of the prototype 35 the skin . As mentioned, any of the apparatuses described
with rectangular electrode patches 2615 , 2617 attached herein may be configured for use with dry ( also referred to
FIG . 26D shows a similar view without the electrodes herein as " self re -wetting” or simply " self-wetting” ) elec
attached . trodes. In particular, described herein are electrodes and
As mentioned , any of the apparatuses described herein apparatuses including such electrodes that may be wetted
may include electrodes ( e. g ., electrode patches ) that couple 40 ( automatically or manually ) using a vaporizer (mister or
to the body of the neck -wearable apparatus (neckband, torc , source of mist). It may be particularly advantageous to
etc .) . In some variations the electrode ( s ) may form part of a include a source of mist that is based on vibration ( e . g .,
cartridge or package that that may include one or more gel sonic /ultrasonic vibration ) using a piezo . For example , as
pads that connect via adhesion or mechanical contact to described herein , the TES waveforms found to be effective
couple to the apparatus ; these electrodes may be replaced by 45 to invoke the neuromodulator effects desired may a range of
the user. In practice, this may mean that the apparatus, frequencies that are also effective for vibrating a piezoelec
including electrodes, may be assembled before placing the tric transducer to produce a mist.
device on the neck . Alternatively , as mentioned above, the For example , a piezoelectric ceramic discs operating at
electrodes may be applied to the neck , then coupled ( e . g ., the frequency between 100 KHz to 2 MHz is known to
magnetically ) to the neck -wearable body of the apparatus. 50 create droplets when the piezo disc is immersed in a fluid .
One example of a cartridge or electrode assembly that In any of the apparatuses described herein , a piezoelectric
may be coupled to the apparatus may include a double - sided , vaporizer may be included to apply mist ( e . g ., of saline or
conductive gel pad with a flood print of silver on carbon other conductive fluid ) onto the electrode surface / skin inter
PVC film between gel. This film may help buffer the DC face (which may be a sponge or the like ) either continuously
reduction and oxidation reactions, as well as help disperse 55 or discretely ( in intervals ) to maintain the conductive con
the current. The electrode formed in this manner may then nection between the dry electrode and the subject 's skin . The
be coupled to the apparatus through an electrical connector moisture ( vapor ) applied may be regulated by feedback
in any appropriate manner. In some variations, a gel pad may based on the electrical contact determined between the
adhere to one or more conductive contacts on the device subject's skin and the electrode and/ or one or more other
made of an inert conductor like carbon , gold or stainless 60 sensors . A piezo driver may require a voltage between 20
steel contacts . Gel pads may have a backing material to Volt to 100 Volt to create the mist .
improve handling; and may include a blank space through Any of the apparatuses described herein may include a
which contact between the apparatus conductive contact and controller (local controller ) for controlling the application of
a gel body is feasible . In some variations the backing electrical energy to the electrodes. The same controller, or a
material can match the size /shape of the conductive contact 65 separate controller, may be used to control the vaporizer in
to key where the gel body should be placed on the device . applying vapor to the electrode( s ). For example , any of the
The gel body portion of an electrode patch can also be apparatuses may include a switching power supply that uses
US 9, 956 , 405 B2
25 26
a frequency of oscillation between 100 KHz to 2 MHz. To ratus that uses a skin -contacting electrode, including wear
apply vapor to the electrodes, the high frequency from the able electronics in general (for either or both sensing and
power supply may be rectified to create DC for waveforms stimulation ).
(e. g., ensemble waveforms, TES waveforms) applied to In implanting the self -rewetting electrode a fluid reservoir
evoke the cognitive effect(s ). Power may also be taken from 5 including an electrically conductive fluid (e .g., saline) may
the power supply before rectification , and the voltage be included in the apparatus ( including as part of a cartridge
applied to a piezo driver ( e.g ., disc ) at a corresponding or refillable (e .g., by user). The reservoir may be included as
resonance frequency, causing the disc to vibrate and gener part of the wearable (e. g., the elongate body , such as the
ate droplets of vapor that may be delivered as conductive electrode-coupling region , etc .). The vaporizer (the piezo
material onto the dry electrode. Thus, in some variations the material) may be on the apparatus, including in contact with
oscillating power source (also referred to as a switching the electrode, and particularly the skin - contacting surface of
power source ) driving the TES waveformsmay be adapted the electrode and/ or it may be separate and positioned to
for use with the vaporizer, to provide power for the atomizer direct the stream of vapor on the users skin and /or directly
without additional circuitry or increasing size of the appa- 15 onto the skin -contacting surface . In some variations the
ratus. vaporizer is behind , beside , surrounding or surrounded by
The piezo driver (e .g ., disc ) can be embedded into the dry the electrode .
electrode , or submersed in a small reservoir built into the Alternatively or additionally , a re -wettable and /or clean
apparatus ( including the elongate body / torc body of the able electrodemay include a storage compartment the holds,
neck -worn apparatus ). For example, in some cases the 20 rewets and / or cleans the electrodes between uses. For
apparatus may include an ultrasound mist generator having example , FIGS. 27A - 27C illustrate one example of a neck
a matrix of laser drilled holes on the center of the piezo ( e . g ., worn TES apparatus that includes a pair of electrodes
ceramic disc ) that are less than 2 cm in diameter (e .g ., coupled to an electrode support (permanently or removably ).
between about 0 .5 mm and 2 cm , between about 0 . 5 mm and The electrodes 2705 , 2707 in this variation may be folded
1 cm , between about 0 .5 mm and 8 mm , between about 0 . 5 25 together, as shown in FIG . 27A , so that they can be placed
mm and 7 mm , between about 0 .5 mm and 5 mm , between in a storage compartment when not in use . The storage
about 0 . 5 mm and 3 mm , between about 0 .5 mm and 2 mm . compartment may clean and/ or rewet the electrode surfaces
(skin contacting surfaces ) which may include a gel and/or
between about 0.5 mm and 1 mm , etc .); the piezo may be sponge as mentioned . Thus in this example the torc body
thin (e .g., between 0.5 mm and 5 mm thick , between 0 .5 mm+ 30 2703 includes a hinge region 2709 or couples to the hinge
and 4 mm , between about 0.5 mm and 3 mm , between about 30 region . The electrodes may open outwards, as shown in
0 .5 mm and 2 mm , etc .). In operation , fluid may be wicked FIGS. 27B and 27C . In some variations the electrodes may
from the bottom side of the piezo through the holes , and then
may be atomized by the ultrasound vibration on the " air be removable , as shown in FIG . 28 , leaving the hinge region
2709 to which new , refurbished , or the original electrodes
side” of the piezo.
In some example of self- rewetting electrodes as described| 35 mayAsagain be attached /coupled .
herein , an embed ultrasound transducer may be posited ones o shown inin FIGFIGS
shown . 30A -30C , in variations such as the
. 27A - 27C , the electrodes may be placed
behind a gel (or sponge ) contacting the electrode ( forming and held in a chamber that can rewet them between uses. In
the skin -contacting surface of the electrode ). The skin . FIG . 29 , a cross - section of the electrodes 2905 , 2907 held
contacting surface may be in a dry state during storage . 40 within an example of a rewetting cartridge are shown. In this
When a gel is used , the gel may be a matrix that absorbs fluid example , the rewetting cartridge includes a fluid reservoir
( e .g ., saline) when the mist is applied , but may dry out 2903 ( e .g ., full of saline or another conductive fluid ). When
completely or near completely after vapor is no longer not in use, the rewetting cartridge may be placed over the
applied . electrodes. In some variations the cartridge may also be
FIG . 32 illustrates a prototype of a vaporizer that may be 45 configured to clean the skin - contacting surfaces , e. g ., during
used to rewet one or more electrodes when incorporated into the process of inserting the electrodes into / out of the car
any of the apparatuses described herein . In this example , a tridge .
1 mm thick ultrasound (piezoelectric ) disk 3203 has a 1 cm FIG . 30A shows an example of a pair of electrodes ( only
diameter has later drilled holes through its center. When a one is visible 3005 in this example ) held within a cartridge
high frequency signal ( e . g ., 190 KHZ) is applied to the disc 50 3003 . The cartridge folds over the electrodes, placing their
at fairly low power, the disc vibrates and throws droplets of skin -contacting surfaces in contact with a wicking material
fluid (mist 3205 ) into air, as illustrated against the dark 3008 (e . g ., fiber, sponge , etc .) that is wetted by the fluid
background . Capillary action then replenishes fluid from the reservoir. In this example , the cartridge includes a pair of
back side of the disc . In practice , only a very small amount doors that can fasten over the electrodes, as shown in FIGS .
of fluid needs to be vaporized (for a brief period of time) to 55 30B and 30C . When stored in the cartridge , the electrodes
wet an electrode. For example, in the example shown in FIG . are wetted by the apparatus. In some variations the cartridge
32 , once the ultrasound turns on (within 2 second or less may include a vaporizer such as those described above , for
( e . g ., within 1 second , 0 . 8 second , 0 . 7 seconds, 0 .6 seconds, applying fluid to the skin - contacting surface ( s ) of the elec
0 .5 seconds , 0 . 4 seconds , etc . or less ), the electrode is trodes. FIG . 31 shows a schematic illustration , including
sufficiently wet and makes the appropriate electrical con - 60 exemplary dimensions ( in mm ), of a rewetting cartridge .
nection to skin . The holes through the piezo material ( e . g ., In some variations, the apparatus may be used with a
disk ) may be small enough so that fluid will not spill from stand . For example , the rewetting cartridge may be config
the reservoir. ured as a stand ; alternatively , the stand may be used to clean
As previously mentioned , although the examples pro - and store the electrodes and protect the electrode surfaces
vided here may include such self-wetting electrodes as part 65 when not in use . In some variations the stand may include
of TES apparatus as described herein , in general such refilling ( e . g ., of conductive fluid ) and / or recharging ( e . g ., of
self -rewetting electrodesmay be incorporated into any appa- battery ) between uses .
US 9, 956 , 405 B2
27 28
For example , FIGS. 33A - 33B and 34A -34B illustrate one however the separation 3709' between the electrodes (near
example of a stand thatmay be used . In FIG . 33A , the stand est edge to nearest edge) is closer to 2 inches (e.g ., between
is also configured as a cartridge having a clam shell con 1 .8 and 2 . 2 inches ). In general, the minimum distance
figuration . The electrodes in this example may be small between the electrodes may provide field penetration of
(larger electrodes may be used ). When the stand /cartridge is 5 sufficient depth so that the energy is not simply shunted
closed , thematerials that touch the electrodes may rehydrate across the subject 's skin . Without being bound to a particular
and/ or clean them . The cartridge is shown open in FIGS. theory of operation , this may allow stimulation of the
33A (back ) and 33B (front), allowing the device to be cervical nerves . However, if the electrodes are too far apart,
inserted therein . In FIGS. 34A and 34B , the apparatus is the energy applied may be too diffuse or may require a larger
inserted into the cartridge and the cartridge is shown as 10 output energy . Surprisingly, having the electrodes separated
closed , with the hinged door shut so that the electrodes and by approximately 1 inch (nearest edge to nearest edge )
a portion of the elongate (torc ) body held therein . works, and indeed works particularly well.
Neck Placement In addition , maintaining the electrodes in this region of
In any of the apparatuses described herein , as shown and
described above, the apparatuses may be positioned so that 15 me neck (or neck and back ), so that the pair of electrodes are
positioned so that 15 the
the electrode (s ) contact the user ( e .g ., subject ) behind the positioned on the skin over the lower cervical/ upper thoracic
neck . Both electrodes may be positioned behind the neck . region is surprisingly more comfortable and effective than
FIG . 35 illustrates an example of an apparatus 3501 worn on placement in other regions , particularly other neck and /or
a user ' s neck /back 3505 . In general, these electrodes may be head regions. In this configuration at least one of the
positioned along the cervical region and /or the upper tho- 20 electrodes (e .g., the lower electrode ) may be highly stable,
racic locations e . g ., C1-C7 and T1 - T2 . For example , in some even while the subject moves his or her neck and head ,
variations the electrodes contact the user with a first (upper, preventing discomfort and avoiding dislodging the appara
e .g., anode ) at C4 /C5 and a second (lower, e .g ., cathode) at tus
C7 (referring to the locations over the user 's skin above The anode and cathode electrodes may be arranged in any
corresponding cervical regions C4 /C5 and C7) . 25 orientation ( e . g ., vertically relative to the long axis of the
In some variations the lower electrode may be positioned user 's body, horizontally , etc .). In some variations itmay be
on the skin over the upper thoracic region of the spine ; the beneficial for the electrodes to be arranged vertically relative
upper electrode may also be positioned over the upper to the long-axis of the user's body (e .g., from the head to the
thoracic region or in the lower cervical region . For example . feet). For example , the electrodesmay be arranged with the
FIGS. 37A - 37C illustrate variations with this positioning. In 30 electrodes vertically aligned , one on top of the other. Sur
FIG . 37A , the pair of electrodes includes a first electrode prisingly, in some configurations parallel vertical strips
3701 in which the upper electrode is within the lower covering the area do not seem to work as well . One preferred
cervical region ( e .g ., on the skin over the C4 - C6 region of placement may be to place the anode at the base of the neck
the spine ), while the second electrode 3703 is also over the (e .g ., versus just below the hairline ) and the cathode down
lower cervical region of the spine ( e. g ., on the skin over the 35 ward from there, correspondingly to the top of the back . This
C3-C7 region of the spine ). More preferably, as shown in arrangement may provide optimal effect (e.g ., cognitive
FIG . 37B , the upper electrode 3701 is positioned over the effect, while minimizing discomfort).
lower cervical region (e.g ., C6 -C7) while the lower electrode FIGS. 36A - 36D illustrate another example of a neck
3703 is positioned at the top of the thoracic region ( e . g ., worn TES apparatus that may be used as described herein .
T1 -T2). In FIGS. 37A - 37B , the division between the cervi - 40 In this example , the TES apparatus includes a rigid or
cal and thoracic region is approximately shown by dashed semi-rigid frame 3603 . In some variations the framemay be
line 3705 . The upper and lower electrodes may be part of an formed of a polymeric material, such as a plastic material,
electrode pad that is separate from or integral with the TES including metallized plastics . The inner surface of the frame
controller device . may be padded , covered , coated , etc. for wearing comfort.
In general, in any of the methods and apparatuses 45 For example , the inner (user - facing ) surface may be
described herein , itmay be beneficial for the electrodes to be wrapped or covered with a fabric 3605 . One or more
arranged so that the first electrode is above the second electrodes , or attachments/ connectors for a disposable elec
electrode when worn on the body along the subject 's ante - trode ( e. g ., strip , pad , contact strip , etc .) may be present on
rior- to -posterior ( e . g . foot -to -head ) longitudinal midline at the inner surface as shown in FIG . 36B , or it may be present
the back of the neck / upper back . The separation between the 50 inside of the surface, or on an outer surface, and the pad may
first and second electrodes may also be important. For extend down /up from the wearable body . FIG . 36A illus
example , the separation may be between 0 .7 inches and 2 trates an example of an electrode strip /pad 3608 extending
inches , preferably between 0 . 8 inches and 1. 4 inches . The from the wearable body . The strip or pad may be snapped or
minimum distance may be between 0 .7 and 1. 2 inches ( e . g ., otherwise coupled to the wearable body. In FIG . 36B the
approximately 1 inch ), from the nearest edge to the nearest 55 inner surface of the body shows a pair of offset connectors
edge . The maximum distance may be between 1 .7 inches for coupling ( in this example , snap - fitting) to the pad . The
and 2 . 2 inches ( e .g ., 2 inches ) from nearest edge to nearest electrodes 3608 may be held against the skin ( e. g ., adhe
edge . For example, as shown in FIG . 37A , the electrodes sively or simply by virtue of the connection to the weight of
may be separated 3709 by an approximately 0 .8 - 1 .5 inch the wearable body ). The body 3603 may also be textured on
distance (nearest edge to nearest edge ) and arranged in an 60 the outer, inner, or both surfaces ( e . g ., an in -mold texture on
anterior to posterior (e . g . foot to head ) longitudinal direc - plastic in this example ). In some variations the connections
tion , so that the electrodes are stacked atop each other to the electrodes may be present within the housing 3603 ,
relative in the longitudinal axis. which may include a slot, clamp, or the like to hold the
FIG . 37C illustrates an example of an arrangement of the electrode connectors and make connection thereto . Alterna
electrodes in which the upper electrode is on the skin over 65 tively, as described above, the electrodes may be reusable,
the cervical region while the lower electrode is on the skin durable electrodes that are coupled to and /or extend from the
over the thoracic region of the spine, similar to FIG . 37B , wearable body.
US 9 ,956 ,405 B2
29 30
In FIG . 36B the wearable body also includes at least one nection . The TES controlling device may be a lightweight
control (e .g., power button 3609 ) on the body. Additional wearable TES controller device , including those incorpo
controls (buttons , sliders , switches, etc .) may be included ; rated for reference above, which are otherwise configured to
alternatively no buttonsmay be present on the surface, but be worn on the subject 's head . The adapter electrode pad is
it may be powered on /off remotely and/ or controlled 5 therefore configured to adapt these device so that they can be
remotely , e. g ., by a wireless apparatus such as a smartphone worn on the neck , as shown in FIG . 38B .
running control software . FIGS. 39A -411 illustrate an example of a TES controller
The apparatus of FIGS. 36A - 36D includes one or more device that may be used with the neck -only adapter elec
straps 3613 ( e .g ., nylon straps 3611 ) that may be present at trodes pad described herein . FIG . 39A shows the front of a
the ends of the torque - shaped neck worn body and may be 10 TES controller device that is lightweight and configured to
used to attach to an additional component (e . g ., leash , etc .) be worn ( e .g ., on the temple region of the head ). FIG . 39B
or may be configured to attach to clothing or jewelry. The shows a view of the back of the device of FIG . 39A , showing
ends of the arms of the wearable body may be metallic (e.g ., a pair of snap - on connectors 3903, 3905 that provide both
may include metallic endcaps 3621 , as shown in FIG . 36C ). mechanical and electrical connection to the adapter elec
In FIGS. 36C -36D the wearable body may also include one 15 trode pads. In this example , the apparatus body may have
or more indicator light regions 3619 which may be illumi- two (ormore ) parts , including a front body shell that mates
nated by one or more including different color, intensity, with a back body shell and encloses the control circuitry
etc .) light sources, such as LEDs. ( e . g ., processor, battery , wireless communications, buttons/
Adapter Electrode Pads inputs, outputs /LEDs and the like ). FIGS. 40A - 40F illustrate
Although many of the apparatuses andmethods described 20 a frontbody shell, including exemplary dimensions (in mm ),
herein are configured so that the controller ( or stimulator or a nd angles ). Generally , the body 4001 may be configured to
controller /stimulator ) apparatus for applying transdermal mate with the back body shell. FIGS. 41A -411 illustrate an
electrical stimulation ( TES) to the back of a subject's neck example of a back body shell 4101 that may attach to the
to modify a user 's cognitive state (e . g ., to induce a relaxed front body shell.
state ) includes a wearable torc body that extends around the 25 Any of the wearable TES controller devices described
subject' s neck , these techniques may be configured so that herein , including the wearable example shown in FIGS . 39B
the controller apparatus is a small , lightweight and wearable and 40A -411, may couple with a neck -only adapter electrode
apparatus that does not extend around the neck . For pad . In addition , any of the neck -worn controllers described
example , any of the TES stimulator apparatuses described in above, may also be configured to be worn or connected to
the following patent applications (herein incorporated by 30 these adapter electrode pads . FIGS. 42A - 42C illustrate an
reference in their entirety ) may be adapted for use in neck example of a neck -only adapter electrode pad .
(and particularly C3 - T2 neck /back ) only stimulation : In FIG . 42A , the adapter electrode pad includes a pair of
US- 2014 -0148872 ; US - 2015 -0088224 ; US - 2016 -0008632; connectors 4203, 4205 that are shown as male snap type
US - 2015 - 0005840 ; US - 2015 -0005841; US - 2015 -0174403 ; connectors that may make an mechanical and electrical
US - 2015 -0238762; US - 2016 -0317809; US - 2015 -0035877; 35 connection with the TES controller device, as shown in FIG .
US - 2015 - 0335876 ; US - 2016 - 0346545 ; US - 2015 - 0335875 ; 38B . The electrode pad is generally flat, and is configured so
US - 2015 -0335888 ; US - 2015 -0328461; US - 2015 -0328467 ; that it can be flexible , yet provide good contact between an
US-2016 -0346530 ; and US - 2017 - 0076414 . The apparatuses upper electrode 4207 and the skin and a lower electrode
described therein typically include a wearable portion that 4209 . As shown in FIG . 42B , the upper electrode may be
couples to an electrode (often referred to as a cantilever 40 separated from the lower electrode ( closet edge to closet
electrode) and generally connectbetween the subject' s fore - edge 4211 ) by between about 0 .8 inches and 2 . 5 inches . In
head and a location on the back of the subject' s neck or FIG . 42B the distance is approximately 1 inch .
behind the ear. Thus, these TES controller devices are The electrode pad shown in FIGS. 42A -42C are config
configured to couple with an electrode pad on the temple ured for applying transdermal electrical stimulation (TES) to
region of the subject' s head , and may be adapted to have a 45 the back of a subject ' s neck to modify a user ' s cognitive
body shape that is well suited for this location . Described state . Any of these electrode pads may include a flat sub
herein are electrode pads ( referred to as adapter electrode strate 4281 ; the first ( e . g . upper ) electrode 4207 on a first
pads) that are configured to apply the TES to the C3- T2 side of the flat substrate and a second (e . g ., lower ) electrode
neck /back region of the skin which have surprisingly been 4209 also on the first side . As mentioned , the closest edge of
found to be both comfortable and effective, even as com - 50 the first electrode is separated from a closest edge of the
pared to the application at the head and neck . second electrode by between 0 . 8 inches and 2 inches 4211 .
For example , FIGS. 38A - 38B illustrate the use of an These electrode pads may also include a first male snap
adapter electrode pad 3801 (also referred to herein as a connector 4203 that is electrically connected to the first
neck -only electrode pad ) that is configured to be worn over electrode and extends from the substrate on a second side of
the C3 -T2 spinal region on the skin , in which the closest- 55 the flat substrate that is opposite from the first side . A second
edge to closest -edge separation between the first and second male snap connector 4205 electrically connects to the sec
electrode of the pair of electrodes is separated by between ond electrode and extends from the substrate on the second
0 .8 inches and 2 .5 inches ( e. g ., 0 . 8 inches and 1 .6 inches ). side .
In this example , the adapter electrode pad 3801 is placed on In any of these patches it is surprisingly advantageous ,
the skin over the C3 - T2 region of the spine , so that the 60 particularly so that the TES controller may fit onto the neck
electrodes are arranged in themidline of the back /neck in the to allow neck bending and head motion , to arrange the first
longitudinal anterior -to - posterior axis, with the lower elec - electrode and the second electrode in a first line that is
trode over the C5 - T2 region . This is shown in FIG . 38A . In parallel to a longest axis of the electrode pad , and arrange the
this example, the adapter electrode pad includes a pair of first male snap connector (or whatever type of connector is
male connectors , shown configured as snaps having protru - 65 used ) and the second male snap connector (ow whatever
sions which mate with female connectors on a TES control- type of connector is used ) in a second line that is at an angle
ler device 3803, providing mechanical and electrical con - of between 25 and 65 degrees relative to the first line ( e.g .,
US 9 ,956 ,405 B2
31 32
between 15 and 60 degrees , between 30 and 60 degrees, The design of the electrode pads shown in FIGS. 42A
approximately 45 degrees, etc . ). This angled arrangement 45B may be particularly well suited to manufacturing them
has surprisingly proven to be particularly helpful in allowing in a roll or sheet, as shown in FIG . 45C . To use , the
the vertical arrangement of the electrodes on the body electrodes may be peeled off of the pad , as shown. Alterna
(back / neck ) while permitting the TES controller /simulator 5 tively , they may be cut or formed for individual packaging ,
to be worn without impeding movement or irritating the as shown in FIG . 46 , showing a pouch 4601 into which the
subject ( also referred to throughout as the " user " ) . electrode pad 4603 may be placed . This pouch may be
In any of these variations, the electrode pad may be sealed , and marked 4604 including marking with a unique
adhesively held to the skin . For example , the first side may code and /or lot number.
comprise an adhesive. As mentioned , the flat substrate may 10 When a feature or element is herein referred to as being
have a two - lobed ( e. g ., bi- lobed ) shape . The first electrode “ on ” another feature or element, it can be directly on the
and the first and second male snap connectors may be on a other feature or element or intervening features and / or
first lobe of the flat substrate and wherein the second elements may also be present. In contrast, when a feature or
electrode may be on a second lobe of the flat substrate , as element is referred to as being directly on ” another feature
shown in FIGS. 42A -42C . The second electrode may extend 15 or element, there are no intervening features or elements
beyond the perimeter of the flat substrate , as shown . In present. It will also be understood that, when a feature or
general, the second electrode may be larger than the first element is referred to as being “ connected " , " attached or
electrode . For example , the surface area of the second " coupled ” to another feature or element, it can be directly
electrode may be greater than 1 . 25 times ( e . g ., greater than connected , attached or coupled to the other feature or
1 .4x , greater than 1 . 5x , greater than 1 .6x, greater than 1 .7x , 20 element or intervening features or elements may be present.
greater than 1 .8x , greater than 1 .9x , greater than 2x , etc .) the In contrast, when a feature or element is referred to as being
surface area of the first electrode. As mentioned , the closest “ directly connected ” , “ directly attached ” or “ directly
edge of the first electrode may be separated from the closest coupled ” to another feature or element, there are no inter
edge of the second electrode by between 0 . 9 and 1. 5 inches, vening features or elements present. Although described or
preferably around 1 inch . 25 shown with respect to one embodiment, the features and
In this example, the electrode pad is formed from a elements so described or shown can apply to other embodi
flexible substrate onto which each electrode is formed by ments . It will also be appreciated by those of skill in the art
adding layers, as illustrated schematically in FIGS. 43A that references to a structure or feature that is disposed
44E . " adjacent” another feature may have portions that overlap or
For example , as shown in FIG . 43A , showing a bottom 30 underlie the adjacent feature.
side of the electrode pad substrate for an electrode pad such T erminology used herein is for the purpose of describing
as that shown in FIGS. 42A -42C , with exemplary dimen particular embodiments only and is not intended to be
sions shown, the substrate 4301 is cut into the bi- lobed shape limiting of the invention . For example , as used herein , the
shown (the upper lobe is roughly triangular and the lower singular forms “ a ” , “ an ” and “ the” are intended to include
lobe is circular ) ; the upper portion includes through -holes 35 the plural forms as well, unless the context clearly indicates
4305 for connecting to the male connectors . The electrical otherwise. It will be further understood that the terms
contacts may be formed onto this substrate . The electrical " comprises ” and / or " comprising, " when used in this speci
contacts ( first and second electrodes , as well as any con fication , specify the presence of stated features , steps , opera
necting electrical trace ) may be formed by any appropriate tions, elements, and /or components , but do not preclude the
means, including screen printing, deposition , etc . FIG . 43B 40 presence or addition of one or more other features, steps,
shows the top side of the substrate of the electrode pad . operations, elements , components , and /or groups thereof. As
Conductive traces formed of silver 4311 or other conductive used herein , the term “ and / or ” includes any and all combi
materialmay be printed onto the substrate , as shown in FIG . nations of one ormore of the associated listed items and may
43C . A second conductive layer ( e . g ., carbon ) 4312 may be be abbreviated as “ /” .
printed over this layer, having a slightly larger perimeter, as 45 Spatially relative terms, such as " under ” , “ below ” ,
shown in FIG . 43D . Finally an insulative (dielectric ) layer “ lower” , " over” , “ upper” and the like, may be used herein
4313 may be printed over these , with openings where for ease of description to describe one element or feature ' s
conductive contacts will be made with the other portions relationship to another element( s ) or feature ( s ) as illustrated
forming the spreading region (and skin - contacting surfaces ) in the figures . It will be understood that the spatially relative
of the electrodes, described in reference to FIGS. 44A -44E , 50 terms are intended to encompass different orientations of the
below . In addition , a dielectric may be printed over the top device in use or operation in addition to the orientation
layer , as shown in FIG . 43F . depicted in the figures. For example, if a device in the figures
FIG . 44 shows an assembled electrode pad , including a is inverted , elements described as " under” or “ beneath ”
top electrode 4401 and a bottom electrode 4402 . A liner other elements or features would then be oriented “ over ” the
4403 and a liner label 4404 are also shown . As shown in 55 other elements or features. Thus , the exemplary term
FIG . 44D , the electrodes may be built up of layers . These “ under” can encompass both an orientation of over and
layers may be formed of a release liner and a silver ( con - under. The device may be otherwise oriented (rotated 90
ductive ) layer and /or a conductive gel (hydrocolloid ); and degrees or at other orientations ) and the spatially relative
additional adhesive may also be included . FIGS. 44E - 44G descriptors used herein interpreted accordingly . Similarly ,
illustrate similar layers for the second electrode , including a 60 the terms " upwardly ” , “ downwardly ” , " vertical" , " horizon
hydrogel layer ( 2A ), a silver/carbon layer (2B ), a second tal” and the like are used herein for the purpose of expla
hydrogel layer (2C ) a foam ( 2D ), and a release liner ( 2E ). nation only unless specifically indicated otherwise .
The electrode pad may include text or writing that pro - Although the terms “ first ” and “ second ” may be used
vides instructions for applying and / or removing the elec - herein to describe various features / elements ( including
trode pad , as shown in FIG . 45A - 45B . In some variations. 65 steps ), these features/elements should not be limited by
This writing may be adhesively applied ( 4 ) to the back of the these terms, unless the context indicates otherwise . These
electrode pad . termsmay be used to distinguish one feature /element from
US 9, 956 , 405 B2
33 34
another feature/element. Thus, a first feature /element dis - provided primarily for exemplary purposes and should not
cussed below could be termed a second feature /element, and be interpreted to limit the scope of the invention as it is set
similarly , a second feature / element discussed below could forth in the claims.
be termed a first feature/ element without departing from the The examples and illustrations included herein show , by
teachings of the present invention . 5 way of illustration and not of limitation , specific embodi
Throughout this specification and the claims which fol ments in which the subject matter may be practiced . As
low , unless the context requires otherwise , the word " com mentioned , other embodiments may be utilized and derived
prise ” , and variations such as “ comprises ” and “ comprising " . there from , such that structural and logical substitutions and
means various components can be co -jointly employed in changes may be made without departing from the scope of
the methods and articles (e .g., compositions and apparatuses 10 this th disclosure. Such embodiments of the inventive subject
including device and methods). For example , the term matter may be referred to herein individually or collectively
" comprising” will be understood to imply the inclusion of by the term " invention ” merely for convenience and without
any stated elements or steps but not the exclusion of any intending to voluntarily limit the scope of this application to
other elements or steps. In general, any of the apparatuses
and methods described herein should be understood to be 1515 any any single
single invention or inventive concept, if more than one
inclusive , but all or a sub -set of the components and / or steps is, in fact, disclosed . Thus, although specific embodiments
may alternatively be exclusive, and may be expressed as have been illustrated and described herein , any arrangement
" consisting of” or alternatively " consisting essentially of” calculated to achieve the same purpose may be substituted
the various components , steps, sub - components or sub - for the specific embodiments shown. This disclosure is
steps . 20 intended to cover any and all adaptations or variations of
As used herein in the specification and claims, including various embodiments . Combinations of the above embodi
as used in the examples and unless otherwise expressly ments, and other embodiments not specifically described
specified , all numbers may be read as if prefaced by the word herein , will be apparent to those of skill in the art upon
" about” or “ approximately,” even if the term does not reviewing the above description .
expressly appear. The phrase " about” or “ approximately ” 25
may be used when describing magnitude and /or position to What is claimed is:
indicate that the value and/ or position described is within a 1. A method ofapplying transdermal electrical stimulation
reasonable expected range of values and /or positions. For ( TES ) to the back of a user 's neck to induce a relaxed state ,
re
example , a numeric value may have a value that is + / - 0 . 1 % the method comprising:
of the stated value ( or range of values ), + / - 1 % of the stated 30 placing an anode and a cathode along a midline of a back
value ( or range of values ), + / - 2 % of the stated value (or of the user 's neck between a region over the user 's C3
range of values), + / - 5 % of the stated value ( or range of cervical region and the user 's T2 thoracic region,
values ), + / - 10 % of the stated value ( or range of values ), etc . wherein the anode is separated from the cathode by
Any numerical values given herein should also be under between 0 .8 and 2 . 2 inches;
stood to include about or approximately that value , unless 35 applying electrical energy between the anode and the
the context indicates otherwise . For example , if the value cathode to deliver TES ; and
“ 10 ” is disclosed , then “ about 10 ” is also disclosed . Any inducing , in the user, a relaxed state by the application of
numerical range recited herein is intended to include all TES .
sub -ranges subsumed therein . It is also understood that when 2 . The method of claim 1 , wherein placing comprises
a value is disclosed that “ less than or equal to ” the value, 40 adhesively attaching the anode and the cathode .
" greater than or equal to the value” and possible ranges 3. The method of claim 1, wherein placing comprises
between values are also disclosed , as appropriately under placing the anode and the cathode so that the anode is
stood by the skilled artisan . For example, if the value “ X ” is separated from the cathode by between 0 .8 inches and 2 .0
disclosed the “ less than or equal to X ” as well as " greater inches , and wherein the anode and the cathode are arranged
than or equal to X ” ( e . g ., where X is a numerical value ) is 45 along themidline of the user' s body so that the anode is over
also disclosed . It is also understood that the throughout the the user 's C4 -C7 region and the cathode is over the user' s
application , data is provided in a number of different for - C7 - T2 region .
mats, and that this data , represents endpoints and starting 4 . The method of claim 1, wherein placing comprises
points , and ranges for any combination of the data points. adhesively attaching an electrode pad comprising the anode
For example , if a particular data point “ 10 ” and a particular 50 and the cathode to the back of a user' s neck so that the anode
data point “ 15 ” are disclosed , it is understood that greater and the cathode are arranged along the midline of the user' s
than , greater than or equal to , less than , less than or equal to , neck .
and equal to 10 and 15 are considered disclosed as well as 5 . The method of claim 1 , wherein placing the anode
between 10 and 15 . It is also understood that each unit comprises placing a neck -worn TES controller around the
between two particular units are also disclosed . For 55 neck of the user wherein the TES controller is configured to
example, if 10 and 15 are disclosed , then 11 , 12 , 13 , and 14 apply electrical energy between the anode and the cathode .
are also disclosed . 6 . The method of claim 1, wherein applying electrical
Although various illustrative embodiments are described energy comprises applying TES by delivering electrical
above , any of a number of changes may be made to various energy between the anode and the cathode , wherein the
embodiments without departing from the scope of the inven - 60 electrical energy comprises a carrier wave having a fre
tion as described by the claims. For example, the order in quency that is greater than 250 Hz that is amplitude modu
which various described method steps are performed may lated at a frequency that is ten percent or less of the
often be changed in alternative embodiments, and in other frequency of the carrier wave , further wherein the amplitude
alternative embodiments one or more method steps may be modulation is varied at least once every 40 seconds .
skipped altogether. Optional features of various device and 65 7. The method of claim 6 , wherein the amplitude modu
system embodiments may be included in some embodiments lation is varied by varying the shape of an envelope of the
and not in others . Therefore , the foregoing description is amplitude modulation .
US 9 ,956 ,405 B2
35 36
8 . The method of claim 6 , wherein the amplitude modu 15 . The method of claim 13 , wherein placing comprises
lation is varied by varying one or both of a symmetry ratio attaching a wearable TES controller to the anode and the
and a flat ratio of the amplitude modulation . cathode.
9 . The method of claim 1 , wherein a surface area of one 16 . The method of claim 13, wherein applying TES by
of the anode is greater than 1 . 25 times the surface area of the 5 delivering electrical energy comprises applying the energy
cathode . at a rise time of between 1 and 20 microseconds.
10 . The method of claim I , wherein placing comprises 17 . The method of claim 16 , wherein the rise -time is
attaching a wearable TES controller to the anode and the varied between 1 and 20 microseconds.
cathode. 18 . The method of claim 13, wherein applying TES
11 . The method of claim 1 , wherein inducing the relaxed 10 comprises applying the carrier wave with a rise time of
state comprises one or more of: reducing stress , reducing between 1 and 20 microseconds.
anxiety , improving sleep , and improve mood .
19 . The
12 . The method of claim 1, wherein inducing a relaxed varied between method of claim 18 , wherein the rise - time is
state comprises lowering one or more of: blood pressure , 1 and 20 microseconds.
heart rate , and skin conductance. 15 20 . The method of claim 13 , wherein a surface area of one
13 . A method of applying transdermal electrical stimula of the anode is greater than 1. 25 times the surface area of the
tion ( TES ) to induce a relaxed state , the method comprising: cathode .
placing an anode and a cathode to a back of the user' s state 21. The method of claim 13 , wherein inducing the relaxed
neck along a midline of a long axis of the user ' s body comprises one ormore of: reducing stress , reducing
anxiety
extending anterior to posterior, wherein the anode is 20 22 . The , improving sleep , and improve mood .
positioned over the user ' s C3 - C7 region and the cath method of claim 13 , wherein inducing a relaxed
ode is positioned over the user' s C7 - T2 region, wherein state comprises lowering one or more of: blood pressure ,
the anode and the cathode form part of an electrode heart rate, and skin conductance .
23 . A method of applying transdermal electrical stimula
pad , and wherein the anode is separated from the
cathode by between 0 .8 and 2 .0 inches; tion (TES ) to the back of a user' s neck , the method com
applying TES by delivering electrical energy between the prising
anode and the cathode, wherein the electrical energy placing an anode and a cathode along a midline of a back
comprises a carrier wave having a frequency that is of the user 's neck between a region over the user's C3
greater than 250 Hz that is amplitude modulated at a cervical region and the user ' s T2 thoracic region ,
frequency that is ten percent or less the frequency of the 30 wherein the anode is separated from the cathode by
carrier wave ; and between 0 .6 and 1. 3 inches ;
inducing, in the user, a relaxed state by the application of applying electrical energy between the anode and the
TES . cathode to deliver TES; and
14 . The method of claim 13 , wherein placing comprises modulating , in the user, the user 's parasympathetic drive
placing a TES controller around the user 's neck or shoulders 35 and the user's sympathetic drive by the application of
wherein the TES controller is configured to apply electrical TES .
energy between the anode and the cathode. * * * * *

United States Patent: (10) Patent No .: US 9, 956, 405 B2 (45) Date of Patent: May 1, 2018

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United States Patent: (10) Patent No .: US 9, 956, 405 B2 (45) Date of Patent: May 1, 2018

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THIONVIULUI DAT HITTATURALE DI TALK

(12) United States Patent ( 10) Patent No.: US 9, 956 ,405 B2

(51) Int. Cl. 9 ,014 ,811 B2 4 / 2015 Pal et al.

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