2023

JAN

Authors:
Raquel Medina-Ramírez, PhD, PT
All rights reserved to
Fabiola Molina-Cedrés, PT
David Álamo-Arce, PT, PDI

Partners:
Content
1. INTRODUCTION.................................................................................................................................2

2. NESA NON-INVASIVE NEUROMODULATION APPLICATION..................................3

3. SCIENTIFIC EVIDENCE AND CLINICAL ADVANCES......................................................7

4. DEVELOPMENT AND CLINICAL RESEARCH OF NON-INVASIVE

NEUROMODULATION NESA..........................................................................................................16

REFERENCES..........................................................................................................................................34

RESOURCES AND LINKS..................................................................................................................42

1.
 NS
3
130ms
2,5
23,26
-+-+-+-+-+-+-+-+-+
+-+-+-+-+-+-+-+-+-

Figure 2. Body diagram of the locations of the 4 electrodes and the

targeting electrode. The division into semi-electrodes is further appreciated.
The XSIGNAL® current transmitter introduces its signals through 24 electrodes located at the ends of
both hands and both feet, as shown in the picture. The directional electrode acts as a grounding
electrode, concentrating the impulses on specific areas. These areas are explained below under types of
application. For the application of gloves and anklets, it is necessary to remove metal objects from the
patient, and to clean the skin where the electrodes are placed. Attention should be paid to the size
required for each patient, in order to match the electrodes to the prescribed locations and to achieve
good contact of the metal with the skin.

Figure 5 . Color clasification of electrodes.

Wrist Ankle
1.Radial nerve (anterior branch) 1.superficial peroneal nerve

2.Radial nerve (posterior branch) 2. Saphenous nerve

3. Ulnar nerve (anterior branch) 3. Sural sensitive nerve

4. Ulnar nerve (cutaneous branch) 4. Tibial nerve (calcaneal branches)

5. Median nerve (palm branch) 5. Superficial peroneal nerve

6. Ulnar nerve (dorsal branch) 6. Deep peroneal nerve

Figure 6. Nerves description bay semi-electrode.

Figure 7. Graphic representation of the placement of the electrodes on the patient, in a passive application modality. The Xsignal device is
appreciated on its table adapted for easy placement.
3. SCIENTIFIC EVIDENCE AND CLINICAL ADVANCES

3.1 CLINICAL AND SCIENTIFIC ADVANCES IN NEUROLOGY

3.1.1. Implications in neurology

The physioelectric characteristics of the NESA microcurrents allow the neuromodulation of the ANS at the
systemic level. It produces modulations in the autonomic neuronal cascade and promote the normalization
of electrically dysfunctional or pathological systems (R. Becker, 1998). As explained above, the propagation of
current facilitates its transmission through the B fibers responsible for the preganglionic connection of the
autonomic nervous system and the unmyelinated C fibers.

Special consideration should be given to the complete activation of the sympathetic system concept. It is
produced by very intense emotional or painful stimuli that produce an activation of the sympathetic system
throughout the organism through the hypothalamus. We can call this profile sympathetic-activated patients,
and we can identify them thanks to the anamnesis at the first consultation. (McCorry, 2007). Nesa
neuromodulation can help decrease the activation described. As is known, the role played by the autonomic
nervous system in the generation and maintenance of certain painful states is significant (Knudsen et al.,
2019). Thus, after certain injuries (Mischkowski et al., 2018), some changes can be observed as a consequence
of the important modulation of this kind of systems. Moreover, those systems which involves central
sensitization pain mechanisms and ANS (Drewes et al., 2020).

Some preliminary studies in the field of neurology are showing improvements in diseases such as complex
regional syndrome (Molina et al., 2020), trigeminal neuralgia (Lledó-Amat, ancho-Francés, et al., 2021); changes
in the patient's quality of life of with Multiple Sclerosis (Contreras & Medina-Ramírez, 2021) and in patients
with cerebrovascular accidents (Lledó-Amat, et al., 2021).

In pediatric neurology, a double-blind randomized clinical trial with a control group (trial code: CEIC
HUGCDN: 2019-474-1) is being developed with the aim of determining the effectiveness of superficial
neurostimulation in children with neurodevelopmental disorders for improvement of constipation and quality
of sleep (San Juan de Dios Hospital, Las Palmas de Gran Canaria, Spain) (Báez-Suárez et al., 2020).

Nowadays, a new line in geriatrics has been started with the objectives; to evaluate and improve the quality of
sleep, stress and anxiety in people residing in Spanish health centers.
3.1.2 Implications for Vagus neuromodulation

The vagus nerve plays a crucial role in redirecting nerve impulses when ANS is neuromolating or systemic
body. The mechanism of action of the NESA microcurrents in the neuromodulation of the Vagus can be
multifactorial for the CNS; neuromodulating propagated cortical depression and inhibiting posterior
trigeminal vascular nociceptive pathways (Chen et al., 2016), acting on the trigeminal-cervical complex
(Akerman et al., 2017) and parasympathetic pathways (Möller et al., 2018). For this reason, it is an important ally
in migraine and headaches, especially in cluster headaches (CR).

As it is global neuromodulation, the Vagus also plays an important role in the transmission of cascade
modulation (Capitán Maestrando, 2013) through its vast network reaching the solar plexus and mesenteric
nervous system, where sympathetic and parasympathetic fibers are combined. (Bouchet, 1979) allowing
clinical results in pathologies that affect this area.

A physiological study has recently been started where it is expected to measure changes in the evoked
potentials of both Median Nerves, Tibial Nerves, and Vagus Nerves, as well as to measure the somatosensory
cortex corresponding to each one, before and after performing the 10 sessions. The objective of programming,
therefore, will be firstly not to generate adverse effects on the patient; secondly, to enhance the effects on the
nervous system that the device can generate, in a homogeneous way; and thirdly, to focus the action on the
nerves. Peripherals and the cranial nerve being measured.

Figure 8. 3D details of the extension of the vagus nerve and mesenteric plexus.

3.1.3 Implications for neuromodulation of the cardiovascular system

Non-invasive neuromodulation NESA can produce changes in cardiac variability related to the ANS, although
possible studies related to the parameter of cardiac variability in pathologies or optimization of sports training
are still under development.
3.2 CLINICAL AND SCIENTIFIC ADVANCES IN REHABILITATION

3.2.1 Implications for sports rehabilitation and physiotherapy

Anxiety and concentration can be variables that affect sports performance, the first defined as an organism's
response to external and internal stimuli, and the second as a psychic process that includes reasoning in terms
of achieving a specific goal.
The need to find new and ecological variables focused on training adaptations and the recovery process in
team sports players during training and competitive matches has increased in recent years (Coutts et al., 2017).
Impellizzeri et al. defined internal load as a set of athlete responses in the presence of predominant
physiological, psychological and biomechanical stressors due to external load during training sessions and
matches (Impellizzeri et al., 2019). Heart rate variability (HRV), enzyme activity (for example, CK or cortisol or
testosterone concentrations), or subjective perceptions (RPE, well-being, or DOMS) are indicators of adaptation
and recovery or variables of indirect effects of internal load, instead of internal load variables (Kellmann et al.,
2018; Vanrenterghem et al., 2017).

Non-invasive neuromodulation can act against all conditions that cause excitement and tension in the
cerebral nervous, osteoarticular muscular, and visceral vascular systems, as well as improve the concentration
levels of the players. It is currently applied in sports treatments, in soccer, badminton, runners and basketball.

Preliminary studies in soccer players have shown improvements in the experimental groups with significant
differences (p-value = 0.041) for the quality of sleep with the application of NESA, compared to placebo groups.
Recently, a double-blind randomized clinical trial (006 / CEICGC / 2021) is finishing the objective of which was
to improve neural efficiency (improve performance and stress, improve coordination in the field, improve sleep
quality, improve well-being of the athlete and reduce fatigue) and the performance of basketball players
through a post-training NESA treatment. Preliminary results show significant differences (pvalue = 0.007;
pvalue = 0.000; pvalue = 0.000) for the improvement of the quality of sleep (duration, REM and total sleep
time) related to the biomarkers indicative of muscle damage and the loads applied in the intervention group.
Both studies are in the publication phase.

D. Junior Moraes D. Sergio Canales D. Diego Perotti D. David López D.Chimy Ávila
Shaktar Donesk FC Real Betis balón pie ROMA FC RDC Espanyol CA Osasuna

Dña Carolina Marín D. Mario Román Athletic Club de Bilbao TREK SEGAFREDO Club Deportivo Tenerife
C. Olímpica Badmintón C. Mundo de Super Enduro Fútbol Ciclismo profesional Fútbol

Figure 9. Athletes with the application of non-invasive neuromodulation NESA and its portable versatility.
3.2.2 Implications for trauma rehabilitation

The implication of the neuromodulation of the autonomic nervous system in the improvement of injuries of a
traumatic nature is also being widely studied. The application objectives are based on the improvement of
pain, quality of life, functionality, acceleration of recovery and therefore to generate more effective and efficient
units in the treatment of patients.

A study was carried out in patients diagnosed with whiplash occurring while traveling, thanks to the
collaboration of a mutual organization, where the results showed a correlation in the improvement of pain and
mobility. (see annex of studies).

Currently, a double-blind randomized clinical trial with a control group is active (CHUNSC_2020_97 PRONES
Study) where it is intended to demonstrate that treatment with non-invasive neuromodulation NESA
compared with usual treatment reduces pain, improves quality of life and functionality, both in the early
postoperative phase, as well as in the medium and long term in postoperative patients undergoing total knee
replacement. (see annex of studies).

Another of the current studies is the randomized double-blind clinical trial with a control group in
patients undergoing ACL surgery (CPMP / ICH / 135/95), where its objective is focused on accelerating the
patient's recovery process after ACL surgery and reduce the associated economic costs.

Figure 10. 3D representation of the application of non-invasive NESA neuromodulation showing the wrist half-
electrodes and the directional electrode in a focal treatment, with determined localization.
3.3 CLINICAL AND SCIENTIFIC ADVANCES IN UROLOGY AND GYNECOLOGY

3.3.1 Implications in Overactive Bladder

Urinary Incontinence is a condition that causes involuntary urine leakage. There are two types of
incontinence, that associated with efforts and the striated muscles of the pelvic floor, incontinence
associated with the sensation of urgent urination not related to efforts. This last type of incontinence is
associated with Overactive Bladder Syndrome. The International Continence Society (ICS) defined in 2002
the Overactive Bladder Syndrome (OAB) as a syndrome characterized by the presence of urinary urgency
isolated or in combination with other symptoms, such as Urge Urinary Incontinence (UUI), generally
associated with an increase in the frequency of voiding and nocturia, in the absence of another
demonstrable disease (Alcántara Montero, 2016).

Men and women with OAB symptoms report low levels of quality of life related to health and work
productivity, as well as high levels of anxiety and depression compared to those who have no symptoms or
with minimal symptoms (Coyne et al., 2011). In Spain a population study was carried out to measure the
incidence of OAB. The prevalence of the general population> 40 years is 21.5%, being higher in women
(25.6%) than in men (17.4%). Only 28.4% of the subjects with compatible symptoms had been diagnosed
with HIV and only 16.7% were receiving treatment (Castro et al., 2005).

OAB presents a multifactorial etiopathogenesis, being possible a neurogenic, urothelial, myogenic or

idiopathic origin. Any of these mechanisms can produce symptoms associated with OAB. The increased
contractility of the overactive detrusor is due to hypersensitivity of the muscarinic receptors (M2 or M3).
Acetylcholine released in the sympathetic nervous system pathways causes the activation of M3 receptors,
responsible for bladder contraction (Wein Alan J. & Rackley Raymond R., 2006).

The treatment of OAB is staggered, goes through a process of bladder reeducation, pelvic floor exercises,
changes in lifestyle and pharmacology. Neurostimulation is part of the recommended therapeutic
algorithm in cases that are resistant to initial treatment. In this sense, NESA microcurrents are presented as
an alternative whose purpose directly affects some of the possible known etiologies of OAB, such as
neurogenic origin, detrusor hyperactivity and the release of acetylcholine by the autonomic nervous
system.

A double-blind randomized clinical trial with a control group is currently active to verify the efficacy of
NESA neuromodulation in women with OAB (Clinical Trials Code NCT04120545). The objective is to verify
the decrease in the voiding diary and the improvement in the quality of life compared to a placebo group,
in 10 sessions distributed twice a week. The pilot study carried out previously had satisfactory results that
lasted over time, in such a way that the current trial aims to reaffirm and disseminate the results previously
obtained.
3.3.2 Implications in Erectile Dysfunction

Male erection depends on involuntary reflexes from the parasympathetic nervous system, which trigger
vasodilation, located in the sacral segments of S2-S4 and the central nervous system, specifically the
midbrain and the limbic cortex. The somatic pathway also plays an important role in erection. When
activated, corpuscular receptors and free endings located in the penis send signals that travel through the
dorsal nerve of the penis, a branch of the pudendal nerve, until reaching the posterior horn of the spinal
cord at the S2-S4 level. From here they ascend the spinothalamic and spinoreticular pathways to sensory
perception in the somatosensory cortex and the thalamus in the central nervous system. Once the
information is processed, a response is produced in the ONUF nuclei of S2-S4, causing the contraction of
the ischiocavernosus muscles through the pudendal nerve (Ceballos et al., 2015).
The parasympathetic nervous system triggers the peripheral neurotransmitter response, the main one
being acetylcholine, which is released by inhibition of noradrenergic presynaptic release and by
stimulation thanks to the release of endothelial nitrous oxide. At the central level, the erection is
associated with dopamine, which produces an erection without sexual stimulation, with serotonin and
oxytocin, which increases the blood concentration during sexual intercourse.
The etiology of ED can have an organic component, such as vascular, neurogenic, anatomical or
endocrinological, or on the other hand a psychogenic cause (Ceballos et al., 2015). In those cases where
dysfunction depends on neurogenic factors or psychological factors associated with anxiety or depression,
a clinical improvement in erectile dysfunction has been observed, thanks to the modulation by the NESA
microcurrents of the autonomic nervous system. In those cases where the main etiological component is
the vascular factor, no progress has been observed. The comfort in the application of the treatment, its
innocuousness, and its ease to compare it with the placebo opens a path of investigation in which to
justify the results observed in the clinic.

3.3.3 Implications in Gynecology

In gynecology, pathologies associated with long-lasting pain processes are sometimes observed, either
due to neuropathies derived from surgical processes, neuropathies associated to psychogenic causes
(pudendal nerve neuropathy), or complex pain such as those that can derive from endometriosis.
The evolution of pain is variable depending on the etiology. In pain with a nociceptive component, where
the tissue registers damage, the pain sensation on the part of the patient decreases as the tissue heals
and remodels. In those cases of long-standing pain, where the perception of pain exceeds the natural
history of tissue healing, and no other justified causes are found, the pain can be considered neuropathic,
even when neurophysiological tests do not register it.
The nervous system plays a major role in the registration, transport and interpretation of the pain signal, in
such a way that the psychosocial components of the patient influence its perception to an excessive
extent (Gifford & Butler, 1997). The efficacy of NESA technology in relieving neuropathic pain has been
observed in the clinic (Molina et al., 2020), even in long-standing cases. The application of resonance
therapy with adequate clinical reasoning, and a number of sessions in proportion to the time of evolution
of the affliction, results in a comfortable and effective treatment for the patient. It will be necessary to
develop both its use and the research that concerns it, in order to be able to solve situations of uncertain
prognosis, such as those observed in most neuropathies that exceed the sixth month of evolution
(Costigan et al., 2009).
3.4. CLINICAL AND SCIENTIFIC ADVANCES IN THE TREATMENT OF PAIN

The NESA microcurrents favor the physiological orthodromic flow of the bioelectricity of the nervous
system, especially in those areas where it has been altered by some dysfunction (R. Becker, 1998). Pain
manifests as an electrical signal within the metabolism, which is registered, transported to higher centers,
interpreted and from which a response is generated (Gifford & Butler, 1997). When pain is maintained over
time or certain injuries occur (Mischkowski 2018), changes are observed in the pain perception and
modulation system, pattern-generating neurons are activated, turning a symptom into a pathology in
itself. Pain sensitization that occurs centrally is believed to be largely maintained by the autonomic
nervous system (Knudsen et al. 2019).

The psychosocial implications and the impact on the quality of life that is generated in patients with
chronic pain are invalidating. It is necessary to adopt effective and less invasive strategies for this sector of
the population, which is estimated to be 17% in Spain, and to solve the current deficiency in the
management of chronic pain (Torralba et al., 2014).

The influence generated by global neuromodulation NESA on the nervous system, restores by repetition
of electrical patterns, including the ANS-dependent pain modulation system, marking the physiological
rhythms that should predominate in a healthy individual. It is therefore to be understood that those
patients with long-term and highly affected painful pathologies will need a longer exposure to the
microcurrent than those patients with milder characteristics and a closer evolution.

In this way, with the application of the NESA X Signar microcurrent device, for example, the decrease in
pain by 8 points on the VAS scale of a complex regional syndrome of upper limb of 2 years of evolution in
13 sessions has been observed, spread over 5 weeks (Molina et al., 2020).

The treatment of fibromyalgia, complex pain or central sensitization syndromes, involves understanding,
in the first instance, its etiology. Understanding the functioning of the nervous system as a whole, and the
succession of events that lead a person to suffer from fluctuating and incessant pain for years, without the
tissues being involved, is something that puzzles both clinicians and patients. The multidisciplinary
approach and the socio-family support is essential, but innovation, the development of technologies and
the implementation of these within the reach of users is even more essential at this time. Improvements
in sleep quality, fatigue and pain reduction have been observed clinically in patients with fibromyalgia of
more than 10 years of evolution, after performing between 3 and 10 months of treatment with the NESA
microcurrents, times in line with the duration of the evolution of each case.

The treatment of headaches, especially of some migraine syndromes, is possible with the application of
this technology, in a high percentage observed in the clinic, sometimes with the resolution of the crisis, at
the end of the application of the device. These observations should be demonstrated in the future
through clinical trials, and would mean a change in the understanding of the etiology of certain
conditions, as well as an improvement in the quality of life of the patients involved.
3.5. IMPLICATIONS AND ADVANCES IN SLEEP MEDICINE

Insufficient sleep or sleep disorders are directly related to cardiovascular disease, diabetes, being
overweight, obesity, stress, accidents, and importantly with immune and neurocognitive dysfunction.
As scientific studies show. Complementing the above, the analysis of studies carried out to date reveals
that the quality of sleep and the immune response have a strong relationship and in turn with the
autonomic nervous system. Sleep deprivation results in poor immune function: it decreases the
production of antibodies by vaccines, the number and activity of NK cells, as well as the production of
IL-2 and induces an increase in the circulation of pro-inflammatory markers IL-6, TNF-α and C-reactive
protein. ultimately resulting in alterations of the vegetative nervous system and sympathetic-
parasympathetic regulation.

Therefore, given the current situation in which we live, we need to increase strategies that facilitate the
consolidation and quality of sleep. Within the therapeutic arsenal, we consider that the use of Non-
Invasive Neuromodulation, through the NESA XSIGNAL device, can contribute to this factor and,
therefore, to the improvement of the immune system response.

Figure 11. 3D graphic drawing representing the production of melatonin and its secretion to the
blood vessels of the brain.

6.1 Implications in sleep treatment

In order to improve the quality of sleep, taking into account the diversity of etiologies of sleep dysfunctions,
a new opportunity is presented to include, as an adjunct, non-invasive neuromodulation NESA to current
sleep treatment methods. Due to the non-invasive and painless application of neuromodulation, NESA is a
complementary treatment to the rest available in patients with alterations in the quality of sleep.
The diverse origin of sleep disorders makes their treatment and diagnosis complex, however, preliminary
studies have shown an improvement in the quality of sleep in soccer athletes by applying NESA non-
invasive neuromodulation sessions three times a week for 15 sessions. post-training. Applying program 7 for
100% of the time between 45 and 90 minutes, after one or two sessions with previous preparation programs
(P1 50% of the time, P7 50% remaining), will allow the autonomic nervous system to be modulated, but it will
have an impact different depending on the location of the directing electrode. The main recommended
location is C6-C7, with a higher incidence in the reticular formation of the medulla oblongata, after the cases
registered in the clinic and in preliminary studies.
In the last clinical trial carried out on professional basketball players, characterized by stressful situations that
alter the quality of sleep, preliminary results with significant differences (p-value = 0.007; p-value = 0.000; p-
value = 0.000) show for the improvement of the quality of sleep. (duration, REM and total sleep time) related
to biomarkers indicative of muscle damage and applied loads in the intervention group. Correlations are
currently being studied, in addition, with cortisol and creatine kinase levels.

For future lines and taking into account the potential of melatonin as well as the improvement in the quality
of sleep through the regulation of circadian rhythms as agents to counteract the consequences of the
COVID-19 pandemic, the non-invasive application and painless neuromodulation NESA can be a
complementary treatment to the rest available in post-covid patients from the point of view of respiratory
physiotherapy and electrotherapy focused on the autonomic nervous system.

Taking into account the direct evidence of the application of respiratory physiotherapy in ICU units and the
reduction in hospital stay, a complementary treatment to these physiotherapy techniques, such as non-
invasive neuromodulation, can generate advances in the evolution of these patients. The first cases that are
being studied are revealing an acceleration in the recovery of post-covid patients both in their symptoms
and in the quality of sleep, envisioning a promising future in helping to treat patients with sequelae caused
by the affectation of the COVID-19.

Figure 12. Left: Image with the cervical location of the targeting electrode, in central treatment. Right: Saliva cortisol level
meter with collector and buffer.
4. DEVELOPMENT AND CLINICAL RESEARCH IN NON-
INVASIVE NEUROMODULATION NESA
This section aims to expose the reader to the different lines of research that have been and are being
developed by different working groups that we will now proceed to describe:

4.1 FINISHED STUDIES

"Efficacy of treatment with the NESA Xsignal® electrostimulator in patients with post-
traumatic neck pain"
Institution: Service of Rehabilitation ACTIVA Mutua Madrid-Barcelona-Córdoba.

Abstract: 21 patients with the diagnosis Whiplash have been evaluated (grade I-II cervical injury qualification,
following the Foreman and Croft Classification). Said evaluation has been carried out with the biomechanical
analysis system "Biomek" (Movement analysis is carried out using three-dimensional videophotogrammetry -
motion capture using several infrared light emitting cameras) at the beginning of the protocolized
rehabilitation treatment and after 14 days. The physiotherapy protocol consists of the application of an
electrostimulator (NESA XSIGNAL®) combined with active exercise for 14 days in patients diagnosed with post-
traumatic neck pain as a result of an on-the-road traffic accident. Cervical pain and disability questionnaires
are also carried out at the beginning and after 14 days.

Results: Good correlation between the decrease in cervical mobility restriction and the manifestation of pain
and disability in 14 days. Statistically analyzed mobility data (initial assessment vs. evolutionary control) shows a
significant increase in mobility in the 4 movements: flexion, extension, lateral flexion and rotation. In relation to
the values ​of the questionnaires, a decrease in cervical pain and disability is obtained with respect to the initial
values.

Conclusions: Our study shows the usefulness of the biomechanical test to determine the degree of cervical
affectation and to monitor the rehabilitation treatment in order to establish the protocols and apply the new
physical procedures. "
"Superficial neurostimulation aplication electroencephalographic and psychological changes".
Institution: University of Alcalá de Henares.

Summary: 15 subjects (7 women and 8 men), aged between 18 and 88, who showed mild or moderate
anxiety, hostility, and obsessive symptoms (but for a case with severe symptoms), underwent 20 one-hour
sessions each one, at least twice a week and a maximum of 4 times. Program number 7 was applied to them.
They could not receive psychotherapeutic treatment during the study period. The only exclusion criteria
applied were pregnancy, recent myocardial infarction or implanted pacemaker.

Results:
- Most of the subjects had their scores reduced on different scales, in some cases up to 50%. Subjects who do
not go beyond the threshold or whose anxiety, irritability, and obsessive symptoms are at a minimum also
improved as shown on the scales. Neurostimulation could be responsible for an increase in the effects of
psychopharmacology; however, more specific studies are required to confirm this hypothesis.
- The most satisfactory clinical results have been achieved in a frequency range of 7.8 Hz. The most plausible
explanation is based on the Schumann resonances, which would have that as the basic frequency and what
would be the high precision external time base used by the body to control circadian rhythms.

"Comparative study of the frontal EGG activity after superficial neuro-stimulation application,
mindfulness and other attentional techniques." Institution: University of Alcalá de Henares.

Subsequently, the same authors designed a study with the onektivop, with the aim of comparing the
electrical changes observed after the use of non-invasive neuromodulation NESA with other mental
concentration techniques: Mindfulness (mental attention without judgment) and a technique based on
emission of a sound. The application of NESA microcurrents was used and it was evaluated through digital
encephalogram; Faraday cage.

Results The Mindfulness and SNSA techniques show similarities with respect to the frequency of the alpha
rhythm in the frontal regions (Figures 1 and 2) compared to a different mental concentration technology.
nickel (figure 3). However, scalable studies are needed to determine more generalizable results.

Figure 13. Left: Study published in the European Psychiatry Journal. Right: Before and after the application of NESA in the concentrations of
the alpha waves represented in a digital encephalogram.
“Efficacy of non-invasive neuromodulation NESA in improving the quality of sleep and well-
being in soccer players; viability study"
Institution: Alfonso X el Sabio University, Madrid. Spain
Authors: Aparicio, P. Jean, Antonin

Objective: To verify the effectiveness of the application of non-invasive neuromodulation NESA in

improving the quality of sleep and well-being of soccer players of a professional team.

o Determine improvement in sleep quality

o Assess changes in cortisol concentrations related to sleep and stress.
o Check the feasibility of the study for a subsequent clinical trial

Type of Study: Final Degree Project. Prospective intervention feasibility study in two groups of
professional soccer sports subjects (intervention and placebo).

Subjects: Healthy soccer players without previous injuries.

Intervention: 10 sessions, 2 times a week. Applying a central protocol combining P1, P7, P5. P4 and
P8.

Results: After analyzing the results, a significant difference was obtained for the improvement of sleep
quality (pvalue = 0.041) post intervention in the experimental group. And although no differences were
obtained for cortisol levels, a significant Pearson correlation (p-value = 0.009) was observed between the
decrease in post-treatment cortisol and the improvement in sleep quality.

Figura 14. Left: Chart with details of programs applied, time and week of application. Right: Salivary cortisol meter.
"Efficacy of non-invasive neuromodulation NESA in neuroefficiency in basketball players on
the field"
Institution: FC Barcelona, basketball team.
Authors: F. García, D. Fernández, J. Vázquez-Guerrero, R. Font, B. Moreno-Planas, D. Álamo
Arce, R. Medina-Ramírez and M. Mallol-Soler

The competitive calendars of team sports are increasingly compressed, generating changes in the effort-
recovery cycle. Given this new situation, it seems necessary to analyze how it affects semi-professional
players at a physiological and performance level, as well as how to observe if the non-invasive
neuromodulation technique NESA helps the neuroefficiency and concentration values ​of said players.

MAIN OBJECTIVE: Improve the neuroefficiency and performance of basketball players through a post-
training NESA treatment. Likewise, to observe the possible associations between parameters of both
external and internal load and responses after training and games with non-invasive neuromodulation.

DIRECTIONAL
o Improve performance and stress PROGRAM TIME
ELECTRODE
MODE

o Improve coordination in the field

o Improve the quality of sleep. P5 15MIN C7 LOW

o Improve the well-being of the athlete

P7 30MIN C7 LOW
o Reduce fatigue
Figure 15. NESA protocol

METHODS: Randomized clinical trial. For this, a double-blind capture system will be available (neither
the specialist nor those responsible for recovery will know which patients enter the complementary
treatment). At the end of the study, the results obtained between the different groups of patients will be
able to be compared; those additionally treated with a device, those treated with a placebo device and
those in the standard rehabilitation procedure without a device.

RESULTS:
The sample of male basketball players (20.9 (SD
2.4) years; 196.7 (SD 11.5) cm; 89.0 (SD 21.2) kg)
was analyzed for the first phase on sleep, a
significant difference was obtained (pvalue =
<0.001; 0.007 ; <0.001; <0.001) for the
improvement of the variables duration, REM
and total sleep, in the post intervention in the
experimental group. Showing a maintenance
of the quality of sleep of the experimental
sample, especially in the last two weeks where
they entered the playoffs. The rest of the results
are currently being processed.
Figure 16. Paper publication in Frontiers in Physiology journal.
 “Efficacy of the NESA treatment on sleep quality, pain and incontinence in patients with
Multiple Sclerosis. Prospective study"
Insitution: Sinapsis Fisioterapia (Mallorca, Spain) and University of Las Palmas de Gran Canaria
Authors: Contreras, M. Medina, R.

Objective:
The main objective of this study is to improve the sleep quality of patients with Multiple Sclerosis. The secondary
objective was to improve pain perception, control of urinary bladder incontinence neurogena and the
differences between two treatment groups.

Subjects
Patients of a local Multiple Sclerosis association. After an online meeting, the
Potential patients were openly invited. (n=14).

Design
The treatment was for 3 weeks with 15 sessions (one session per day). All participants attended
to an initial visit with an experimental physical therapist to verify the inclusion criteria.
Once the participants were accepted, the sample divided into two groups was randomized through digital
software:
Group A: with NESA microcurrent treatment based on program 2 + program 3 (with electrode
directional electrode located in L1-L3) and program 5 + program 7 (with directional electrode located in C7).
Each program for 15 min.
Group B: with microcurrent NESA treatment based on program 2 + program 6 + program 5 +
program 7 (with directional electrode located at C7). Each program for 15 min.
Outcome measurements were assessed at baseline (before week 1), session 7 (week 2), and after
of session 15 (end of week 3).

Results
Fourteen participants were invited and randomized into group A (n=7) and group B (n=7). After the first week, we
lost three patients to group B (n = 4) due to covid infection. In the analysis of weekday sleep quality in each
group, we found a significant difference in group A (p value = 0.19) and for group B (p value = 0.30) between the
mean of the score of the Pittsburgh scale. In group A, the Pittsburgh score started with a mean of 7.85 points, 6.71
points in the second week and 4.85 in the last week.
For evaluation of incontinence we found
significant differences between weeks in the
CACU test in the area of symptoms (pvalue =
.008) and area of discomfort (pvalue = .086)
exclusively for the group A, with positive
improvement over 3 weeks of treatment. In
addition, in ICIQ_SF test results were observed
significant differences between weeks of
treatment only for group A (pvalue= .13) with a
positive improvement. I don't know found
significant differences for group b.
Finally, for the assessment of pain only
significant differences were observed in group
A between weeks (p-value = 0.022), being lower
Graph 1. The results obtained in each group with respect to the Pittsburgh test are
at the end of treatment. represented in a boxplot. The results for group A are statistically significant.
“Efficacy and safety of the NXSignal® device for the treatment of overactive bladder in urology.
Randomized controlled clinical trial ”.
Institution: Maternal-infant Insular University Hospital Complex of Las Palmas de Gran Canaria and
Hospiten Bellevue (Santa Cruz de Tenerife).
Authors: Conde, G. Matín, A. Medina, R. Baez, A.

Objective: To evaluate the efficacy and safety of the application of NXSignal technology in the treatment of
patients with overactive bladder to improve the mechanism of regulation of bladder function, and,
therefore, of symptoms and quality of life of patients. the patients.
Type of Study: Randomized, open, parallel and controlled clinical trial.

Methods:
The patients will be recruited from the
gynecology consultation (pelvic floor) of
the Insular-Maternal-Infant Hospital
Complex on the island of Gran Canaria
and from the functional urology
consultation of the Hospiten Rambla
hospital on the island of Tenerife. At the
time of recruitment, the specialist
involved in this study will indicate
whether they wish to follow the
treatment algorithm proposed by the
Spanish Association of Urology or the
one proposed in this study by applying
the NXSignal device. A protocol were
used during 10 sessions of 60 minutes, Figure 17. Detail of the programs foreseen in the protocol in the session blocks. The time and
twice a week. location of the directing electrode are also specified.

Results
Comparing the clinical outcomes of patients using the Spanish version of the Overactive Bladder Control
Self-Assessment Questionnaire (CACV), significant differences were obtained for the intervention group
over time for CACV symtoms (p-value=0.04) and CACV discomfort (p-value=0.003). In addition, significant
differences were found for the incontinence questionnaire (ICQF) over time showing a more rapid
improvement in the NESA group. (p-value=0.007). In terms of sleep, significant differences were found in
the intervention group over time, improving by +- 1 point on the Pittsburgh test. No significant differences
were found for either group for the insomnia questionnaire. The intervention group presented a 15%
decrease in nocturia and urge incontinence episodes. However, no differences were obtained between
groups, due to the sample size. In future studies it is recommended to replicate this methodology with a
larger sample.

Conclusion
NESA non-invasive neuromodulation is a treatment that encourages being an ally in urology or pelvic floor
treatment as it shows its potential by demonstrating improvements in sleep, incontinence and overactive
bladder related discomfort.
"Effectiveness of surface neurostimulation in children with neurodevelopmental disorders for
improvement of constipation and sleep quality. Randomized clinical trial."
Institution: Hospital San Juan de Dios, Las Palmas de Gran Canaria.
Authors: Baez, A. Padrón, I. Medina, R

Institution: Ciudad San Juan de Dios, Las Palmas de Gran Canaria.

Objective: To evaluate the effectiveness of the NXSignal device applied in people with
neurodevelopmental disorders, in relation to constipation problems and sleep consolidation.

Study: Randomized double-blind clinical trial with control group and intervention group (CEIC HUGCDN:
2019-474-1).

Subjects: Children attending school at the Ciudad San Juan de Dios Center in Las Palmas de Gran Canaria
with neurodevelopmental disorders.

Intervention: 10 sessions, 3 times per week. A schedule of P2 + P7 (for 60 min) was used throughout the
sessions.

Results: The intervention group showed a significant improvement in the frequency of defecation, going
from less than 3 times per week to more than 4 times per week in 80% of the sample. There was also an
improvement in the number of hours of sleep and a decrease in nighttime awakenings in the intervention
group (see graphs).

Graphs 2 and 3. Left: Evolution of the frequency of defecations results. Right: Evolution of the sleep hours.

Figure 18. Patiens images from the stuty. All patients signed the inform consent to participate and take photos.
“Efficacy of non-invasive neuromodulation treatment in patients with dementia to improve quality of
life, sleep and general functional status”.
Doctoral Thesis of the University of Murcia.
Authors: Teruel, E. Conesa, C. Medina, R.

Objectives:
Know the effectiveness of an adapted therapeutic exercise program and its comparison with non-
invasive neuromodulation through NESA, and both treatments with a control group; to improve sleep
disturbances in patients with dementia.

Type of Study: Randomized, multicenter clinical trial

Methods

This is a randomized, multicenter clinical trial

consisting of 30 patients diagnosed with dementia
who belong to two Alzheimer's and other dementia
associations in the Region of Murcia (AFADE and
AFAMUR). The participants in this study were
divided into three treatment groups (GC: control
group; GEET: experimental group of 52 therapeutic
exercise sessions; GENM: experimental group of 20
non-invasive neuromodulation sessions with the
Nesa device). The variables of sleep quality and
cognitive ability were measured at 4 different
moments of the study using various rating scales. Figure 19. Detail of the programs foreseen in the protocol in
the study. the session blocks. The time and location of the directing
electrode are also specified.

Result
Analysis of the results obtained on the sleep quality variable reveals favorable and significant data for
both experimental treatments after two months. Regarding the follow-up we found a higher score and,
therefore, greater efficacy for sleep disorders with the NESA treatment.

Statistically significant differences

(p=0.002) are found between the three
groups, however, the Nesa group obtains
a higher score on the Lob's Mec scale,
which means that patients in the Nesa
group present less cognitive impairment
in the post-test, at follow-up 1 and follow-
up 2.
Table 2. Detail of the statistics results for the variable LOBO (Mini Mental State
Examination) in all groups.
Conclusions

Non-invasive stimulation through the Nesa device and therapeutic exercise are two effective and non-
pharmacological treatments that provide benefits in sleep disturbance and cognitive functions in
patients with dementia.
 “Qualitative study of effectiveness, safety and Functioning of the NESA xsignal device”.
Institution: Hospital Quiron Sevilla.

Abstract: 10 patients with relative homogeneity in symptoms were evaluated, as well as variables
anthropometric. In all cases, clinically relevant results were recorded in relation to the pain relief. In most
of the registered cases, said improvement was reported before the fifth session of intervention with the
NXsignal device .

“Evaluation of the impact on cognitive performance and inflammatory response parameters

in relation to high intensity exercise in highly trained athletes
(CrossFit ) for the application of superficial neurostimulation”.
Institution: Sant Cugat High Performance Center.

Abstract: Pilot study in which they intervene for 3 months with athletes who practice CrossFit. In a first
phase, a standard resistance strength work session is established. The initial sample was of 20 individuals
of age (21-35 years), who underwent a medical check-up, with analysis blood test and maximal stress test
to rule out inflammatory pathology, discriminate the risk cardiovascular and characterize level of aerobic
fitness. After the first 30 minutes of training, a new blood draw was performed, which will be repeated 2
hours and 30 minutes after the end of the exercise.

On the other hand, once the treatment with NESA Xsignal was completed (90 minutes post-training),
the battery of neurocognitive tests that were developed during the first medical visit and, in relation to
the strength tests, 10 minutes after the end of the exercise, fatigue tests were carried out, similar to the
phase prior to training and at 2 hours and 10 minutes (after blood extraction and post intervention with
NESA Xsignal).

Results:
- The sample was homogeneous.
- There is a tendency to better recover the group with NESA Xsignal , which in turn loses less speed in the
immediate post-exercise.
- The group operated on with the device showed less presence of inflammatory response (level of
cytokines).
- Both groups improved neurocognitive response. The NESA Xsignal group presented a tendency to
improvement of the successes in the tests.
4.2 ACTIVE STUDIES:

“Efficacy of the NXSignal device for the treatment of Anterior Cruciate Ligament injuries. Randomized
controlled clinical trial. "
Institution: Sant Josep-Althaia Clinic; Manresa, Barcelona.

Objective: Accelerate the patient's recovery process after ACL surgery and reduce the associated financial
costs.
-Improved functionality, stability and joint strength.
-Facilitate a decrease in pain during the rehabilitation process.
-Reduce the number of injuries generated after the first 6 months post-surgery.

Type of Study: Randomized double-blind clinical trial with a control group.

Subjects: Patients who are going to have an ACL tear operation, those who undergo the same ACL surgical
technique, operated by the same surgeon, will be chosen.
Analysis: Functional tests (IKDC and LSI), VAS, edema, quality of life (SF-12), encephalography will be
evaluated.
Intervention: 36 sessions, 3 times a week. Phase 1 . 1 time per week phase 2. 1 time every 2 weeks Phase 3.

DIRECTIONAL
PROGRAM TIME MODE
ELECTRODE

P6 30MIN popliteal zone HIGH

P7 30MIN popliteal zone LOW

Figure 20. NESA protocol detailed. We used high mode due to the health conditions of the subjets, elite sporters.

PRONES study: "Influence of NESA technology in post-operative knee recovery".

Institution: Hospital San Juan de Dios de Tenerife.
Authors: Castillo Rodríguez, JC. Afonso, T. Barrio, MA. Dominguez, B. Alvarez, S. Fierro, I. Gil, N.
Rodríguez, Y. Lugo, J. Medrano, R. García, L. Medrano, R. García, L. Fierro J.

Objective: To demonstrate that the treatment with Applied Superficial Neurostimulation compared to
the usual treatment reduces pain, improves quality of life and functionality, both in the early
postoperative phase, as well as in the medium and long term.

Study Type: Double-blind randomized clinical trial with control group

Subjects: People who underwent total knee replacement.

Intervention: 10 sessions of 60 minutes, three times a week. The protocol to be followed will consist of
applying program 6 for 30 minutes, followed by program 7 for the remaining 45 minutes
“Physiotherapy for Persistent COVID Function through Non-Invasive Neuromodulation NESA".
Institution: UPSA, URJC, UFV y ULPGC
Authors: Melian, A. Laguarta, S. Medina, R.

Objective:
Main objective:
Analyze the effects on the quality of life and sleep through the application of the
superficial neuromodulation NESA vs. placebo in women with LC.
To analyze if there is a correlation in the improvement of the perception of the quality of life related to
health.
Assessment of mechanical sensitivity to pain by evaluating the Pain Threshold at
Pressure (UDP).
Analyze the presence of heart rate variability and cortisol values before and after treatment.

Design
This is a triple-blind randomized controlled clinical trial that will be developed in the facilities of the future
University Clinic of the Faculty of Nursing and Physiotherapy Salus Infirmorum of the Pontifical University of
Salamanca. This sample will be divided as follows manner: 30 women who will receive experimental
treatment with NESA Superficial Neuromodulation and 30 women who will do it with a placebo machine
of the same model.

The following are established as selection criteria:

Inclusion criteria
1) Women who have suffered from CP symptoms for more than one year.
2) Present signs of central sensitization.

Exclusion criteria
Age over 60 or under 18.; Male sex (due to hormonal differences that influence the analysis of pain and the
higher prevalence of the disease in females; Previous treatment with surgery.; Prior spinal trauma;
Whiplash; Pregnancy status; Musculoskeletal disease previous (rheumatoid arthritis, reflex sympathetic
dystrophy, fibromyalgia); Pacemaker; electric pump drug dispenser; ; Changes in skin sensitivity;
Pharmacological treatment analgesic or anxiolytic during the study.

Study variables
1. Quality of sleep and quality of life: questionnaires
Pittsburgh, SF-36, and PROMIS Global Health.
2. Cardiac variability: digital blood pressure monitor
(ADC Cuff+ Navy Adult Cuff 23- 40cm BP-9005-11AN-
1MB), pulse oximeter (Quirumed. OXYM4100) and
portable electrocardiogram device and APP weCardio
HC.
3. Central sensitization by assessing the Pressure Pain
Threshold (PDU): algometer Baseline 12-0300 MMT at
cervical level C5-C6, dorsal D5-D6 and tibialis anterior
muscle.
4. Demographic variables: age and group of
intervention.
5. Salivary cortisol
Figure 21. Detail of the programs foreseen in the protocol in
the session blocks. The time and location of the directing
electrode are also specified.
“"Efficacy of noninvasive NESA neuromodulation in fibromyalgia: a randomized, triple-blind clinical
trial."
Institution: Clinicas CIN, UCLM, ULPGC (Spain)
Authors: Gómez, H. Mordillo, L. Dileone, M. ELvira, M. Medina, R. Báez, A.

MAIN OBJECTIVE
To improve the overall level of pain and fatigue in patients diagnosed with fibromyalgia through NESA
noninvasive neuromodulation treatment.
SECONDARY OBJECTIVES
Improve sleep quality
Improve stress and anxiety
Improve quality of life.

Design
Randomized clinical trial. The general configuration of the study consists of recruiting patients with a
previous diagnosis of fibromyalgia. For this purpose, there will be a triple-blind recruitment system
(neither the specialist nor the treatment managers will know which patients enter the complementary
treatment) and two NESA XSIGNAL® devices operating in triple-blind (due to the imperceptibility of the
stimulation performed, there will be a placebo machine and another one applying the treatment).

Sample:
Patients over 18 years of age
Diagnosis of Fibromyalgia meeting ACR 1990/20101,2 criteria, made by a physician, documented by
clinical report.
Diagnosis of Fibromyalgia made at least 12 months ago
Stable baseline treatment in the month prior to inclusion in the study

ESTUDY VARIABLES
Patients will be evaluated in the first session
and after treatment (pre- and post-
treatment):
1. Pain: Visual Analog Scale (VAS) 2.
2. Pain Algometry (18 trigger points in
fibromyalgia).
3. Perceived sleep quality: through a validated
questionnaire of perception of sleep quality,
Pittsburgh questionnaire (Zúñiga-Vera, 2021).
4. Quality of life: FIQ scale
5. Brief Symptom Listing Test: LSB-50.
6. Polysomnography: looking for correlations
with the Pittsburgh questionnaire.
Figure 22. Detail of the programs foreseen in the protocol in
the session blocks. The time and location of the directing
electrode are also specified.

These results are intended to reduce the need to resort to medication with a consequent reduction in the
number of visits to doctors' offices and a final reduction in social and health care costs.
In addition, the simultaneous study of pain and sleep disorders will make it possible in the future to
delineate in greater detail the profile of these patients, allowing for possible new research aimed at
improving the quality of life of patients with this limiting pathology.
"Efficacy and safety of NXSignal applied surface neurostimulation technology for the treatment of
complex regional pain syndrome (CRPS) type I".
Institution: Hospital MAZ de Zaragoza
Authors: Dr. Roque, Báez, A.

Aims: To evaluate the patient's recovery process and pain modulation, shortening the recovery time and
economic costs associated with complex regional pain syndrome type I.
Type of Study: Randomized, open, parallel and controlled clinical trial.

Subjects: For this type of pathology, although it can be presented by people without a traumatic history,
in general they are more frequent after trauma or surgery to the hand or foot. The bibliography cites an
affectation between 0.05% and 35% of these patients. To this, it must be added that only 20-30% of
patients regain their previous functionality and 30-40% of patients achieve a greater or lesser degree of
disability.

Although it can occur at any age, it is more common between the ages of 40 and 50, and is much more
common in women than in men; it is also more frequent in the upper limb than in the lower one; and its
highest incidence occurs after a distal radius fracture (especially if it is comminuted and articular),
especially if it is treated by plaster immobilization.

Intervention: 20 sessions of 60 minutes with a frequency of 4-5 times a week.

Figure 23. Detail of the programs foreseen in the protocol in the session blocks. The time and location of the directing electrode are also specified.
"Efficacy of non-invasive neuromodulation NESA through somatosensory evoked potentials and
sympathetic-cutaneous responses in healthy subjects: feasibility study in physiotherapy"
Institution: University of Las Palmas de Gran Canaria, M Clinic, Physiotherapy Daniel Reig (Jaén)

Somatosensory evoked potentials are crucial in determining the physiological changes of potentials in
nerve pathways. Although their main function is diagnostic, they have recently been used as a
physiological test to determine physioelectric changes in healthy subjects to study applied stimuli, such
as laser, pain or electrotherapy.

Aims
The objective of this study is to determine if there are changes in the somatosensory evoked potentials
of the ulnar, median, tibial, peroneal and vagus nerves when applying non-invasive neuromodulation
NESA, which is used as a physiotherapy treatment for objectives such as pain. , vegetative affectations
and sleep dysfunctions.

Study
The general configuration of the study consists of a study before and after the block of sessions to be
determined, and differences of all the variables measured before and after NESA therapy will be
compared through the mechanisms of somatosensory evocations.

Methods
During the 10 sessions of the treatment, the
programming will evolve to optimize the
response. The treatment will be carried out
centrally to cover the nervous system in a
general way, and with low intensity in order
to avoid adverse effects. The proposal
includes 3 programming phases. A first
phase of preparation of 3 sessions, a second
phase of empowerment and a last phase
that aims to generate changes at the level
of the peripheral nervous system,
specifically the peripheral nerves
(N.Mediano and N.Tibial), in addition to
perpetuating the others objectives
established in the previous phases.

Figure 23. Detail of the programs foreseen in the protocol

in the session blocks. The time and location of the directing
electrode are also specified.
POSTERS
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RESOUCES AND LINKS

MORE INFORMATION:

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How does NESA's non-invasive neuromodulation work? 3D

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UNIVERSITY RESEARCH AGREEMENTS

Alfonso X el Sabio University, NESA® Electrophysiology Laboratory. Scientific investigation.

Research and academic development agreement with the Pontifical University of Salamanca. NESA®

Research agreement University of Alcala de Henares. Pain Institute. Feat. NESA WORLD®

Research agreement University of Castilla La Mancha. UDALI. Feat. NESA WORLD®

NESA CLINICAL TRIALS

Efficacy of non-invasive neuromodulation NESA® in the neuroefficiency of basketball players. 2022

Clinical Trial: Recovery of the Anterior Cruciate Ligament with NESA - Clinica Sant Josep Manresa.

Clinical trial: Peristalsis and sleep in children with cerebral palsy. NESA-Hospital San Juan De Dios

Clinical Trial: Postoperative knee prosthesis NESA - San Juan De Dios Hospital. 2021

Clinical Trial: Overactive Bladder with NESA. HOSPITEN Have. and Gran Canaria Maternal and Child
Hospital.

Clinical Trial / Chronic pain in Complex I regional syndrome. Hospital MAZ Zaragoza and the ULPGC.