NCT04962737

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: University of Las Palmas de Gran Canaria · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-11-28
• Primary completion: 2026-04-15
• Completion: 2026-10-20
• First posted: 2021-07-15
• Last updated: 2025-08-22