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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Device: Non-invasive Neuromodulation

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

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aníbal Báez-Suárez, PhD; Phone Number: 0034 652077692; Email: anibal.baez@ulpgc.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Non-invasive Neuromodulation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University of Las Palmas de Gran Canaria
• Investigators: Principal Investigator: Aníbal Báez-Suárez, PhD, University of Las Palmas de Gran Canaria

Publications and helpful links

General Publications

• 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 nervous system: A consensus statement endorsed by the American Autonomic Society, American Academy of Neurology, and the International Federation of Clinical Neurophysiology. Clin Neurophysiol. 2021 Feb;132(2):666-682. doi: 10.1016/j.clinph.2020.11.024. Epub 2020 Dec 22. Erratum In: Clin Neurophysiol. 2021 May;132(5):1194.
• 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.2008.03.016. Epub 2008 May 16.
• 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/s00702-003-0087-6. Epub 2003 Jan 1.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): March 28, 2024
• Primary Completion (Estimated): August 15, 2024
• Study Completion (Estimated): December 20, 2024

Study Registration Dates

• First Submitted: July 9, 2021
• First Submitted That Met QC Criteria: July 14, 2021
• First Posted (Actual): July 15, 2021

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 7, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Electric Stimulation Therapy; Healthy Volunteers; physical therapy modality; Evoked Potentials
• Other Study ID Numbers: NESAJaen

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No