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

Not Applicable

Completed

• Conditions: Cortical Excitability
• Interventions: Device: theta burst stimulation

• Registration Number: NCT05206162
• Lead Sponsor: University Hospital, Ghent

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 Timeline

• Study Start: 2017-08-02
• Primary Completion: 2017-11-13
• Study Completion: 2017-11-13
• Status Verified: 2022-01
• Study First Submitted: 2022-01-11
• Study First Submitted QC: 2022-01-11
• Study First Posted: 2022-01-25
• Last Update Submitted: 2022-01-31
• Last Update Posted: 2022-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 15

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
continuous theta burst stimulation	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.
sham stimulation	theta burst 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.
intermittent theta burst stimulation	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.

Primary Outcome Measures

Name	Time	Method
TBS-induced modulation of single-pulse TMS-evoked EEG responses (TEPs) - Local Mean Field Power (LMFP) across a region of interest (ROI)	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	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	measurement takes place immediate before and after TBS stimulation train

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Hospital Ghent; 🇧🇪 Ghent, Belgium