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

NCT05639387 | Completed

• 1 other identifier: 2018/0988
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Epilepsy

Outcome Measures

Primary Outcomes (1)

• Measuring the electric activity of the brain evaluating changes in motor evoked potentials (MEPs) and TMS-evoked potentials (TEPs) during transcutaneous nervus vagus stimulation.

  Using transcranial magnetic stimulation (TMS), the influence of the tVNS is measured.

  60 minutes

Study Arms (2)

Group of healthy volunteers (part I)

EXPERIMENTAL

Participants will undergo active tVNS.

Procedure: actual tVNS

Group of healthy volunteers (part II)

SHAM COMPARATOR

Participants will undergo sham tVNS.

Procedure: sham tVNS

Interventions

actual tVNS PROCEDURE

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

Group of healthy volunteers (part I)

sham tVNS PROCEDURE

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

Group of healthy volunteers (part II)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• estimated IQ \> 70
• healthy volunteer, taken from anamensis, clinical neurological examination and clinical estimation of researcher
• no history of central neurological condition
• no treatment with neurotropic drugs
• TMS safety screening questionnaire
• ICF signed

You may not qualify if:

• intracranial metal objects/materials (excl teeth fillings): vascular clips, shrapnell electrodes below stimulation area
• pacemaker, implanted defibrillator, permanent medication pump, cochlear implant or deep brain stimulation (DBS)

Sponsors & Collaborators

• University Ghent: lead

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Paul Boon, MD, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each participant will complete 2 sessions at least one week apart, one with active tVNS and one with sham tVNS.

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: December 6, 2022
• Study Start: February 6, 2019
• Primary Completion: August 19, 2019
• Study Completion: September 1, 2019
• Last Updated: December 6, 2022

Record last verified: 2022-12

Locations

BE (1)