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TMS as a Tool for the Evaluation of Neuromodulatory Effects of Transcutaneous Vagus Nerve Stimulation

NCT05639387 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2022-12-06

No results posted yet for this study

Summary

Transcutaneous vagus nerve stimulation (tVNS) has been investigated as a potential treatment for epilepsy with inconsistent results. The combination of transcranial magnetic stimulation with electromyography (TMS-EMG) and electroencephalography (TMS-EEG) allows to investigate the neuromodulatory effect of interventions such as tVNS by evaluating changes in motor evoked potentials (MEPs) and TMS-evoked potentials (TEPs). The goal of this study is to objectively evaluate the effect of tVNS on cortical excitability with TMS-EMG and TMS-EEG. These findings are expected to provide insight in the mechanism of action and help identify more optimal stimulation paradigms.

In this prospective single-blind cross-over study, 15 healthy subjects will undergo active and sham tVNS during 60 minutes, using a maximum tolerated stimulation current. Single and paired pulse TMS will be delivered over the right-sided motor hotspot to evaluate MEPs and TEPs before and after the intervention.

Conditions

Interventions

PROCEDURE

actual tVNS

Active tVNS (stimulation on cymba conchae --\> nervus vagus stimulation)

PROCEDURE

sham tVNS

Sham tVNS (stimulation on earlobe --\> no nervus vagus stimulation)

Sponsors & Collaborators

  • University Ghent

    lead OTHER

Principal Investigators

  • Paul Boon, MD, PhD · University Hospital, Ghent

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-06
Primary Completion
2019-08-19
Completion
2019-09-01

Countries

  • Belgium

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05639387 on ClinicalTrials.gov