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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-28

Study Completion Date

2026-10-20

Brief Summary

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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.

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Detailed Description

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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

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Healthy Volunteers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Non-invasive Neuromodulation

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

Group Type EXPERIMENTAL

Non-invasive Neuromodulation

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes