Healthy VolunteersNCT04962737
Non-invasive Neuromodulation NESA Through Somatosensory Evoked Potentials and Sympathetic-cutaneous Responses
A study testing Non-invasive Neuromodulation in people with Healthy Volunteers, run by University of Las Palmas de Gran Canaria.
Trial summary
Somatosensory evoked potentials are crucial in determining the physiological changes of potentials in nerve pathways. Although their main function is diagnostic, the investigators have recently been used as a physiological test to determine physioelectric changes in healthy subjects to study applied stimuli, such as… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Non-invasive Neuromodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 28 Nov 2025to 20 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy people
- Optimal cognitive abilities and mentally competent to participate in the study.
- In condition to complete the study questionnaires.
Who cannot join
- Focal mononeuropathies in both upper and lower limbs
- Peripheral neuropathy.
- Patients with implanted functioning pacemakers / defibrillators. Patients with bleeding disorders. Patients being treated with anticoagulants. Patients on antiplatelet therapy.
- Present some of the contraindications for a treatment with NESA XSIGNAL®: pacemakers, internal bleeding, do not apply electrodes on skin in bad condition, with ulcerations or wounds, acute febrile processes, acute thrombophlebitis and / or electricity phobia.
- Not having signed the informed consent.
- Present any injury or pathology during the study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy of Non-invasive Neuromodulation NESA Through Somatosensory Evoked Potentials and Sympathetic-cutaneous Responses in Healthy Subjects
Somatosensory evoked potentials are crucial in determining the physiological changes of potentials in nerve pathways. Although their main function is diagnostic, the investigators 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.
Read the detailed description
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.
Given its potential use, 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 non-invasive neuromodulation NESA is applied, which is used as a physiotherapy treatment. for objectives such as pain, vegetative affectations and sleep disorders.
The variables of the study will be collected at two time points: before the intervention and at the end of the intervention.
The statistical analysis will be an intention-to-treat analysis. For the main outcomes variables a two factor ANOVA will-be performed (intervention-time) with a post-hoc analysis with kruskal wallis correction correction. Statistical significance will be defined as p <0.05
- Conditions
- Healthy Volunteers
- Being tested
- Non-invasive Neuromodulation
- Keywords
- physical therapy modality, Electric Stimulation Therapy, Evoked Potentials, Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive NeuromodulationDevice
The electrodes will be placed with the help of gloves and adapted socks for 1 hour, twice a week, until 10 intervention sessions are completed. In addition, depending on the session, an adhesive electrode will be placed at the level of C7. Characteristics of microcurrents: pulsed monophasic rectangular wave with a pulse of 1.3 s and pause of 300 ms, voltage 3 mV and intensity 0.5 μA.
| Study group | Role | What they receive |
|---|---|---|
| Non-invasive Neuromodulation | Experimental | Non-invasive Neuromodulation Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7 level. Receives: Device: Non-invasive Neuromodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response speed of the central and peripheral nervous system to a stimulus 1
The Somatosensory Evoked Potentials of both median and ulnar nerves will be evaluated.
Neurophysiological tests of the nervous system that functionally assesses the nerve pathways of the central and peripheral nervous system.
For its evaluation, distal stimuli are generated in the wrists in the range of 3-4Hz with intensities above the sensitive threshold and below the pain threshold.
Measured: Up to 1 month
Secondary outcomes (3)
Response speed of the central and peripheral nervous system to a stimulus 2
Somatosensory Evoked Potentials of both Posterior Tibial and Peroneal nerves will be evaluated.
Neurophysiological tests of the nervous system that functionally assesses the nerve pathways of the central and peripheral nervous system.
For its evaluation, distal stimuli are generated in the wrists in the range of 3-4Hz with intensities above the sensitive threshold and below the pain threshold.
Measured: Up to 1 month
Response speed of the central and peripheral nervous system to a stimulus 3
Somatosensory Evoked Potentials of the sensory auricular branch of the vagus nerves will be evaluated.
Neurophysiological tests of the nervous system that functionally assesses the nerve pathways of the central and peripheral nervous system.
Stimulations and recordings will be carried out only in the left auditory pavilion (since the right, due to the connection with the sinoatrial node of the heart by means of vagus efferences, can cause, according to the reports consulted, alteration of the heart rhythm and presyncope). Stimulations will be performed by means of a needle connected to the stimulator equipment, or in the tragus, by means of atrial surface electrode or auriculotherapy needle dipole.
Measured: Up to 1 month
Response speed to sensitive stimuli in the palms of the hand and sole of the feet
Several simultaneous bilateral recordings after stimuli in the palms of the hand and sole of the feet above the sensory threshold in the limb contralateral to the recording, with a time between stimuli greater than one minute, to avoid habituation of the response.
The latency of the first maximum deflection, in millivolts.
Measured: Up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start28 Nov 2025 (estimated)
- Primary completion15 Apr 2026 (estimated)
- Study completion20 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Las Palmas de Gran Canaria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aníbal Báez Suárez, University of Las Palmas de Gran Canaria
- Investigators
- Aníbal Báez-Suárez, PhD, Principal investigator, University of Las Palmas de Gran Canaria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04962737
- Sponsor's protocol ID
- NESAJaen
- Status last verified
- Aug 2025
- First submitted
- 9 Jul 2021
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cheshire WP, Freeman R, Gibbons CH, Cortelli P, Wenning GK, Hilz MJ, Spies JM, Lipp A, Sandroni P, Wada N, Mano A, Ah Kim H, Kimpinski K, Iodice V, Idiaquez J, Thaisetthawatkul P, Coon EA, Low PA, Singer W. Electrodiagnostic assessment of the autonomic nervous system: A consensus statement endorsed by the American Autonomic Society, American Academy of Neurology, and the International Federation of Clinical Neurophysiology. Clin Neurophysiol. 2021 Feb;132(2):666-682. doi: 10.1016/j.clinph.2020.11.024. Epub 2020 Dec 22.
PubMed 33419664Cruccu G, Aminoff MJ, Curio G, Guerit JM, Kakigi R, Mauguiere F, Rossini PM, Treede RD, Garcia-Larrea L. Recommendations for the clinical use of somatosensory-evoked potentials. Clin Neurophysiol. 2008 Aug;119(8):1705-1719. doi: 10.1016/j.clinph.2008.03.016. Epub 2008 May 16.
PubMed 18486546Fallgatter AJ, Neuhauser B, Herrmann MJ, Ehlis AC, Wagener A, Scheuerpflug P, Reiners K, Riederer P. Far field potentials from the brain stem after transcutaneous vagus nerve stimulation. J Neural Transm (Vienna). 2003 Dec;110(12):1437-43. doi: 10.1007/s00702-003-0087-6. Epub 2003 Jan 1.
PubMed 14666414Usami K, Kawai K, Sonoo M, Saito N. Scalp-recorded evoked potentials as a marker for afferent nerve impulse in clinical vagus nerve stimulation. Brain Stimul. 2013 Jul;6(4):615-23. doi: 10.1016/j.brs.2012.09.007. Epub 2012 Oct 11.
PubMed 23088852
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Non-invasive Neuromodulation NESA Through Somatosensory Evoked Potentials and Sympathetic-cutaneous Responses in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04962737
- Acronym / sponsor ID
- NESAJaen
- Conditions
- Healthy Volunteers
- Keywords
- physical therapy modality, Electric Stimulation Therapy, Evoked Potentials, Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of Las Palmas de Gran CanariaUniversity, hospital or other
- Study start
- 28 Nov 2025 (estimated)
- Primary completion
- 15 Apr 2026 (estimated)
- Study completion
- 20 Oct 2026 (estimated)
- First posted
- 15 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Somatosensory evoked potentials are crucial in determining the physiological changes of potentials in nerve pathways. Although their main function is diagnostic, the investigators 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.
Detailed description
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.
Given its potential use, 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 non-invasive neuromodulation NESA is applied, which is used as a physiotherapy treatment. for objectives such as pain, vegetative affectations and sleep disorders.
The variables of the study will be collected at two time points: before the intervention and at the end of the intervention.
The statistical analysis will be an intention-to-treat analysis. For the main outcomes variables a two factor ANOVA will-be performed (intervention-time) with a post-hoc analysis with kruskal wallis correction correction. Statistical significance will be defined as p <0.05
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-invasive Neuromodulation | Experimental | Device: Non-invasive NeuromodulationNon-invasive Neuromodulation Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7 level. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy people
- Optimal cognitive abilities and mentally competent to participate in the study.
- In condition to complete the study questionnaires.
Key exclusion criteria (6 listed)
- Focal mononeuropathies in both upper and lower limbs
- Peripheral neuropathy.
- Patients with implanted functioning pacemakers / defibrillators. Patients with bleeding disorders. Patients being treated with anticoagulants. Patients on antiplatelet therapy.
- Present some of the contraindications for a treatment with NESA XSIGNAL®: pacemakers, internal bleeding, do not apply electrodes on skin in bad condition, with ulcerations or wounds, acute febrile processes, acute thrombophlebitis and / or electricity phobia.
- Not having signed the informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive NeuromodulationThe electrodes will be placed with the help of gloves and adapted socks for 1 hour, twice a week, until 10 intervention sessions are completed. In addition, depending on the session, an adhesive electrode will be placed at the level of C7. Characteristics of microcurrents: pulsed monophasic rectangular wave with a pulse of 1.3 s and pause of 300 ms, voltage 3 mV and intensity 0.5 μA. | Device | Non-invasive Neuromodulation |
Primary outcome
Response speed of the central and peripheral nervous system to a stimulus 1
Time frame: Up to 1 month
The Somatosensory Evoked Potentials of both median and ulnar nerves will be evaluated. Neurophysiological tests of the nervous system that functionally assesses the nerve pathways of the central and peripheral nervous system. For its evaluation, distal stimuli are generated in the wrists in the range of 3-4Hz with intensities above the sensitive threshold and below the pain threshold.
3 secondary outcomes
Response speed of the central and peripheral nervous system to a stimulus 2
Time frame: Up to 1 month
Response speed of the central and peripheral nervous system to a stimulus 3
Time frame: Up to 1 month
Response speed to sensitive stimuli in the palms of the hand and sole of the feet
Time frame: Up to 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Results publication: PubMed 33419664Cheshire WP, Freeman R, Gibbons CH, Cortelli P, Wenning GK, Hilz MJ, Spies JM, Lipp A, Sandroni P, Wada N, Mano A, Ah Kim H, Kimpinski K, Iodice V, Idiaquez J, Thaisetthawatkul P, Coon EA, Low PA, Singer W. Electrodiagnostic assessment of the autonomic nervous system: A consensus statement endorsed by the American Autonomic Society, American Academy of Neurology, and the International Federation of Clinical Neurophysiology. Clin Neurophysiol. 2021 Feb;132(2):666-682. doi: 10.1016/j.clinph.2020.11.024. Epub 2020 Dec 22.
- Results publication: PubMed 18486546Cruccu G, Aminoff MJ, Curio G, Guerit JM, Kakigi R, Mauguiere F, Rossini PM, Treede RD, Garcia-Larrea L. Recommendations for the clinical use of somatosensory-evoked potentials. Clin Neurophysiol. 2008 Aug;119(8):1705-1719. doi: 10.1016/j.clinph.2008.03.016. Epub 2008 May 16.
- Results publication: PubMed 14666414Fallgatter AJ, Neuhauser B, Herrmann MJ, Ehlis AC, Wagener A, Scheuerpflug P, Reiners K, Riederer P. Far field potentials from the brain stem after transcutaneous vagus nerve stimulation. J Neural Transm (Vienna). 2003 Dec;110(12):1437-43. doi: 10.1007/s00702-003-0087-6. Epub 2003 Jan 1.
- Results publication: PubMed 23088852Usami K, Kawai K, Sonoo M, Saito N. Scalp-recorded evoked potentials as a marker for afferent nerve impulse in clinical vagus nerve stimulation. Brain Stimul. 2013 Jul;6(4):615-23. doi: 10.1016/j.brs.2012.09.007. Epub 2012 Oct 11.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aníbal Báez-Suárez, PhD principal investigator
University of Las Palmas de Gran Canaria
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive Neuromodulation in people with Healthy Volunteers, run by University of Las Palmas de Gran Canaria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aníbal Báez-Suárez, PhD (0034 652077692, anibal.baez@ulpgc.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response speed of the central and peripheral nervous system to a stimulus 1 (time frame: Up to 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04962737, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.