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Completed
NCT05639387
TMS as a Tool for the Evaluation of Neuromodulatory Effects of Transcutaneous Vagus Nerve Stimulation
Conditions: Epilepsy
Sex: Male
Ages: 18 Years – 65 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 15
Sponsor: University Ghent
Location: Belgium
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.
Eligibility Criteria
Inclusion Criteria:estimated IQ > 70healthy volunteer, taken from anamensis, clinical neurological examination and clinical estimation of researcherno history of central neurological conditionno treatment with neurotropic drugsTMS safety screening questionnaireICF signedExclusion Criteria:intracranial metal objects/materials (excl teeth fillings): vascular clips, shrapnell electrodes below stimulation areapacemaker, implanted defibrillator, permanent medication pump, cochlear implant or deep brain stimulation (DBS)
Source: ClinicalTrials.gov (NCT05639387). StuddyBuddy aggregates publicly available trial information.