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OpenTrials
Completed

NCT Number: NCT05206162

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.

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Key information

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Ghent

Ghent, 9000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. TBS-induced modulation of single-pulse TMS-evoked EEG responses (TEPs) - peak latency/amplitude of TEP components at Cz

    Time frame: measurement takes place immediate before and after TBS stimulation train

  2. TBS-induced modulation of single-pulse TMS-evoked EEG responses (TEPs) - Local Mean Field Power (LMFP) across a region of interest (ROI)

    Time frame: measurement takes place immediate before and after TBS stimulation train

  3. TBS-induced modulation of single-pulse TMS-evoked EEG responses (TEPs) - divergence index (DI) across all EEG channels

    Time frame: measurement takes place immediate before and after TBS stimulation train

Secondary outcomes

  1. TBS-induced modulation of paired-pulse TMS-evoked EEG responses (TEPs)

    Time frame: measurement takes place immediate before and after TBS stimulation train

  2. TBS-induced modulation of resting-state EEG

    Time frame: measurement takes place immediate before and after a single TBS stimulation train

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 25, 2022
Registry last updated
Feb 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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