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

NCT05206162 | Completed DMC

• 1 other identifier: EC/2017/0780
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Cortical Excitability

Outcome Measures

Primary Outcomes (3)

• 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) - 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) - divergence index (DI) across all EEG channels

  measurement takes place immediate before and after TBS stimulation train

Secondary Outcomes (2)

• 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 Arms (3)

continuous theta burst stimulation

ACTIVE COMPARATOR

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.

Device: theta burst stimulation

intermittent theta burst stimulation

ACTIVE COMPARATOR

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.

Device: theta burst stimulation

sham stimulation

SHAM COMPARATOR

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.

Device: theta burst stimulation

Interventions

theta burst stimulation DEVICE

TBS 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.

continuous theta burst stimulation; intermittent theta burst stimulation; sham stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Publications (1)

• Carrette S, Vonck K, Klooster D, Raedt R, Carrette E, Delbeke J, Wadman W, Casarotto S, Massimini M, Boon P. Exploration of Theta Burst-Induced Modulation of Transcranial Magnetic Stimulation-Evoked Potentials Over the Motor Cortex. Neuromodulation. 2025 Jan;28(1):123-135. doi: 10.1016/j.neurom.2024.04.007. Epub 2024 Jun 5.

  PMID: 38842956 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Boon

Model Details: three experimental sessions at randomized order, at least one week apart, in a cross-over design

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: January 25, 2022
• Study Start: August 2, 2017
• Primary Completion: November 13, 2017
• Study Completion: November 13, 2017
• Last Updated: February 15, 2022

Record last verified: 2022-01

Locations

BE (1)