TMS-EEG as a Tool to Study the Neuromodulatory Effects of Theta Burst Stimulation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- 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)
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Diagnostic
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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)
Arms & Interventions
continuous theta burst stimulation
cTBS over the left motor hotspot, delivered at 80% of resting motor threshold (RMT), according to the Huang et al. protocol, consisting of bursts of stimuli that are presented every 200ms (5Hz), with bursts consisting of 3 stimuli at 50 Hz. A total of 600 pulses are delivered in a continuous train of 40s.
Intervention: theta burst stimulation (Device)
intermittent theta burst stimulation
iTBS over the left motor hotspot, delivered at 80% of resting motor threshold (RMT), according to the Huang et al. protocol, consisting of bursts of stimuli that are presented every 200ms (5Hz), with bursts consisting of 3 stimuli at 50 Hz. A total of 600 pulses are delivered in an intermittent train of 190s for iTBS, with repeated cycles of 2s stimulation and 8s pause.
Intervention: theta burst stimulation (Device)
sham stimulation
Sham stimulation over the left motor hotspot, delivered at 80% of resting motor threshold (RMT), according to the Huang et al. protocol, consisting of bursts of stimuli that are presented every 200ms (5Hz), with bursts consisting of 3 stimuli at 50 Hz. A total of 600 pulses are delivered in a continuous train of 40s using a plastic spacer (25mm thickness) between coil and scalp, preventing effective cortical stimulation.
Intervention: theta burst stimulation (Device)
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)
Investigators
Prof. Dr. Kristl Vonck
Prof. Dr. Boon
University Hospital, Ghent