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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05206162
Enrollment
15
Registered
2022-01-25
Start date
2017-08-02
Completion date
2017-11-13
Last updated
2022-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cortical Excitability

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.

Interventions

DEVICEtheta 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.

Sponsors

University Hospital, Ghent
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

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

Eligibility

Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frame
TBS-induced modulation of single-pulse TMS-evoked EEG responses (TEPs) - peak latency/amplitude of TEP components at Czmeasurement 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 channelsmeasurement takes place immediate before and after TBS stimulation train

Secondary

MeasureTime 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 EEGmeasurement takes place immediate before and after a single TBS stimulation train

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026