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Clinical Trials/NCT05206162
NCT05206162
Completed
Not Applicable

TMS-EEG as a Tool to Study the Neuromodulatory Effects of Theta Burst Stimulation

University Hospital, Ghent1 site in 1 country15 target enrollmentAugust 2, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cortical Excitability
Sponsor
University Hospital, Ghent
Enrollment
15
Locations
1
Primary Endpoint
TBS-induced modulation of single-pulse TMS-evoked EEG responses (TEPs) - Local Mean Field Power (LMFP) across a region of interest (ROI)
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

To assess the effect of continuous (cTBS) and intermittent theta burst stimulation (iTBS) stimulation on motor cortex excitability using TMS-EEG. Based on prior literature, the investigators hypothesized that N100 amplitude would be differently modulated by these two modalities.

Detailed Description

Each participant underwent three experimental sessions, at least one week apart in a cross-over design, assessing the effects of a single TBS train over the motor cortex on TMS-evoked potentials measured at the same location and resting-state EEG, immediately before and after the intervention. At each session a different type of TBS was applied (cTBS, iTBS or sham) in a randomized sequence. Subjects were uninformed about the expected effects of each intervention. Sham stimulation was achieved by adding a plastic spacer (25mm thickness) between coil and scalp, preventing effective cortical stimulation.

Registry
clinicaltrials.gov
Start Date
August 2, 2017
End Date
November 13, 2017
Last Updated
4 years ago
Study Type
Interventional
Study Design
Crossover
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Prof. Dr. Kristl Vonck

Prof. Dr. Boon

University Hospital, Ghent

Eligibility Criteria

Inclusion Criteria

  • Age 18-65 years
  • Right handed subjects
  • Healthy participants, as determined by history, clinical investigation and investigator's judgment
  • No history of central nervous system condition
  • No chronic intake of neurotropic drugs
  • TMS Safety Screening questionnaire and informed consent signed

Exclusion Criteria

  • Pregnancy, short-term birth wish or childbearing age without adequate birth control
  • Intracranial metal hardware (excluding dental filling): surgical clips, shrapnell, electrodes under the stimulation area
  • Presence of pacemaker, implantable cardioverter-defibrillator (ICD), permanent medication pumps, cochlear implants or deep brain stimulation (DBS)

Outcomes

Primary Outcomes

TBS-induced modulation of single-pulse TMS-evoked EEG responses (TEPs) - Local Mean Field Power (LMFP) across a region of interest (ROI)

Time Frame: measurement takes place immediate before and after TBS stimulation train

TBS-induced modulation of single-pulse TMS-evoked EEG responses (TEPs) - peak latency/amplitude of TEP components at Cz

Time Frame: measurement takes place immediate before and after TBS stimulation train

TBS-induced modulation of single-pulse TMS-evoked EEG responses (TEPs) - divergence index (DI) across all EEG channels

Time Frame: measurement takes place immediate before and after TBS stimulation train

Secondary Outcomes

  • TBS-induced modulation of paired-pulse TMS-evoked EEG responses (TEPs)(measurement takes place immediate before and after TBS stimulation train)
  • TBS-induced modulation of resting-state EEG(measurement takes place immediate before and after a single TBS stimulation train)

Study Sites (1)

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