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

University of Las Palmas de Gran Canaria

Status

Not yet enrolling

Conditions

Healthy Volunteers

Treatments

Device: Non-invasive Neuromodulation

Study type

Interventional

Funder types

Other

Identifiers

NCT04962737

NESAJaen

Details and patient eligibility

About

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.

Full 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

Enrollment

15 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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