Non-invasive Neuromodulation NESA Through Somatosensory Evoked Potentials and Sympathetic-cutaneous Responses

NCT04962737 | Not Yet Recruiting

• 1 other identifier: NESAJaen
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief 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 laser, pain or electrotherapy.

Conditions

Healthy Volunteers

Keywords

physical therapy modality; Electric Stimulation Therapy; Evoked Potentials; Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 1 month

Secondary Outcomes (3)

• Response speed of the central and peripheral nervous system to a stimulus 2

  Up to 1 month

• Response speed of the central and peripheral nervous system to a stimulus 3

  Up to 1 month

• Response speed to sensitive stimuli in the palms of the hand and sole of the feet

  Up to 1 month

Study Arms (1)

Non-invasive Neuromodulation

EXPERIMENTAL

Non-invasive Neuromodulation Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7 level.

Device: Non-invasive Neuromodulation

Interventions

Non-invasive Neuromodulation DEVICE

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.

Non-invasive Neuromodulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy people
• Optimal cognitive abilities and mentally competent to participate in the study.
• In condition to complete the study questionnaires.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Las Palmas de Gran Canaria: lead

Related Publications (4)

• 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.

  PMID: 33419664 RESULT

• Cruccu 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.

  PMID: 18486546 RESULT

• Fallgatter 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.

  PMID: 14666414 RESULT

• Usami 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.

  PMID: 23088852 RESULT

Study Officials

• Aníbal Báez-Suárez, PhD

  University of Las Palmas de Gran Canaria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aníbal Báez-Suárez, PhD

CONTACT

0034 652077692; anibal.baez@ulpgc.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 9, 2021
• First Posted: July 15, 2021
• Study Start: November 28, 2025
• Primary Completion: April 15, 2026
• Study Completion (Estimated): October 20, 2026
• Last Updated: August 22, 2025

Record last verified: 2025-08