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

Ghent University Hospital (UZ)

Status: Completed

Conditions: Cortical Excitability

Treatments: Device: theta burst stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05206162

EC/2017/0780

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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15 participants in 3 patient groups

continuous theta burst stimulation

Active Comparator group

Description:

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.

Treatment:

Device: theta burst stimulation

intermittent theta burst stimulation

Active Comparator group

Description:

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.

Treatment:

Device: theta burst stimulation

sham stimulation

Sham Comparator group

Description:

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.

Treatment:

Device: theta burst stimulation