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

Healthy Volunteers Clinical Trial

Official title:

Efficacy of Non-invasive Neuromodulation NESA Through Somatosensory Evoked Potentials and Sympathetic-cutaneous Responses in Healthy Subjects

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04962737
• Other study ID #: NESAJaen
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 28, 2024
• Est. completion date: April 20, 2025

Study information

• Verified date: May 2024
• Source: University of Las Palmas de Gran Canaria
• Contact: Aníbal Báez-Suárez, PhD
• Phone: 0034 652077692
• Email: anibal.baez[@]ulpgc.es
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 laser, pain or electrotherapy.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: April 20, 2025
• Est. primary completion date: November 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy people

• Optimal cognitive abilities and mentally competent to participate in the study.

• In condition to complete the study questionnaires.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Device:
• Non-invasive Neuromodulation
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Las Palmas de Gran Canaria

References & 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 ne — View Citation

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.2008.03.0 — View Citation

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/s0 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Up to 1 month
Secondary	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.	Up to 1 month
Secondary	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.	Up to 1 month