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

Cortical Excitability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05206162
• Other study ID #: EC/2017/0780
• Status: Completed
• Phase: N/A
• Start date: August 2, 2017
• Est. completion date: November 13, 2017

Study information

• Verified date: January 2022
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 13, 2017
• Est. primary completion date: November 13, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cortical Excitability

Intervention

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.

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	TBS-induced modulation of paired-pulse TMS-evoked EEG responses (TEPs)		measurement takes place immediate before and after TBS stimulation train
Secondary	TBS-induced modulation of resting-state EEG		measurement takes place immediate before and after a single TBS stimulation train