Clinical trial NCT05206162: TMS-EEG as a Tool to Study the Neuromodulatory Effects of Theta Burst Stimulation
Official title: TMS-EEG as a Tool to Study the Neuromodulatory Effects of Theta Burst Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cortical Excitability
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2022-01-25
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: three experimental sessions at randomized order, at least one week apart, in a cross-over design
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

* Age 18-65 years
* Male
* Right handed subjects
* IQ \> 70
* 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)

Primary outcomes:
measure: TBS-induced modulation of single-pulse TMS-evoked EEG responses (TEPs) - peak latency/amplitude of TEP components at Cz
timeFrame: measurement takes place immediate before and after TBS stimulation train
measure: TBS-induced modulation of single-pulse TMS-evoked EEG responses (TEPs) - Local Mean Field Power (LMFP) across a region of interest (ROI)
timeFrame: measurement takes place immediate before and after TBS stimulation train
measure: TBS-induced modulation of single-pulse TMS-evoked EEG responses (TEPs) - divergence index (DI) across all EEG channels
timeFrame: measurement takes place immediate before and after TBS stimulation train
Secondary outcomes:
measure: TBS-induced modulation of paired-pulse TMS-evoked EEG responses (TEPs)
timeFrame: measurement takes place immediate before and after TBS stimulation train
measure: TBS-induced modulation of resting-state EEG
timeFrame: measurement takes place immediate before and after a single TBS stimulation train
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
References: