TMS-EEG as a Tool to Study the Neuromodulatory Effects of Theta Burst Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- TBS-induced modulation of single-pulse TMS-evoked EEG responses (TEPs) - Local Mean Field Power (LMFP) across a region of interest (ROI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age 18-65 years
- •Right handed subjects
- •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
排除标准
- •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)
结局指标
主要结局
TBS-induced modulation of single-pulse TMS-evoked EEG responses (TEPs) - Local Mean Field Power (LMFP) across a region of interest (ROI)
时间窗: measurement takes place immediate before and after TBS stimulation train
TBS-induced modulation of single-pulse TMS-evoked EEG responses (TEPs) - peak latency/amplitude of TEP components at Cz
时间窗: 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
时间窗: measurement takes place immediate before and after TBS stimulation train
次要结局
- 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)
研究者
Prof. Dr. Kristl Vonck
Prof. Dr. Boon
University Hospital, Ghent