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

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.

Study Overview

• Status: Completed
• Conditions: Cortical Excitability
• Intervention / Treatment: Device: theta burst stimulation

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • University Hospital Ghent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: theta burst stimulation; 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.
Active Comparator: 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.	Device: theta burst stimulation; 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.
Sham Comparator: 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.	Device: theta burst stimulation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Ghent

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2017
• Primary Completion (Actual): November 13, 2017
• Study Completion (Actual): November 13, 2017

Study Registration Dates

• First Submitted: January 11, 2022
• First Submitted That Met QC Criteria: January 11, 2022
• First Posted (Actual): January 25, 2022

Study Record Updates

• Last Update Posted (Actual): February 15, 2022
• Last Update Submitted That Met QC Criteria: January 31, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: EC/2017/0780

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No