An interventional study of Non-invasive Neuromodulation in Healthy Volunteers, sponsored by University of Las Palmas de Gran Canaria. Not yet recruiting. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-22.
Sponsored by University of Las Palmas de Gran Canaria · Not applicable, Interventional, and Basic science
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.
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
University of Las Palmas de Gran Canaria is the lead sponsor of 23 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Non-invasive Neuromodulation Intervention with microcurrents: application of 6 electrodes per extremity and an adhesive electrode at C7 level.
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.
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.
Time frame: Up to 1 month
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.
Time frame: Up to 1 month
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.
Time frame: Up to 1 month
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.
Time frame: Up to 1 month
No study locations are listed for this record.
Start is estimated for Nov 2025; primary completion for Apr 2026, 4 months later.
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University of Las Palmas de Gran Canaria