The Mechanism of Theta Burst Stimulation (cTBS) in the Treatment of Drug-refractory Epilepsy Targeting the Dentate Nucleus of Cerebellum: An Exploratory Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- TMS evoked potential amplitude change between pre- and post- treatment
研究概览
简要总结
In our previous cross-over study--the continuous θ burst stimulation (cTBS) targeting cerebellum dentate nucleus of 44 drug-refractory epilepsy (DRE) patients, a significant reduction in seizure frequency was observed. However, the mechanism of this target to reduce seizures is still unknown. This study aims to explore the mechanism of cTBS targeting cerebellum dentate nucleus for DRE, in order to provide theoretical support for this treatment method. A total of 50 patients with DRE will have 2-week cTBS treatment via accurate navigation to bilateral cerebellar dentate nucleus. Participants will be took TMS-EEG, functional magnetic resonance imaging, and diffusion tensor imaging (DTI) pre- and post- treatment. These three examinations will help to analyze the brain functional connectivity and suggest the mechanism of action of this treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants aged between 18 and 60,
- •Participants who are in line with the diagnostic criteria for epilepsy and drug-refractory epilepsy (DRE),
- •Participants who have duration of epilepsy ≥ 2 years and seizure frequency ≥ 2 seizures per month,
- •The type and dosage of anti-seizure medications (ASMs) keep unchanged during the experiment,
- •Participants and their families are aware of this study and sign informed consent.
排除标准
- •Participants who are unable to cooperate with treatment and examinations,
- •Participants who are in status epilepticus (SE),
- •Participants who are complicated with a serious infection, cerebrovascular disease, malignant tumour, and other nervous system diseases, with serious dysfunction of heart, liver, kidney, and other organs, and with psychiatric disorders,
- •Participants who are pregnant or breastfeeding,
- •Participants have contraindications of TMS and MRI, that is, the presence of metal or implanted devices in the body, such as cardiac pacemaker, deep brain stimulator, etc,
- •Participants who are in other clinical trials,
- •Participants who withdraw informed consent.
结局指标
主要结局
TMS evoked potential amplitude change between pre- and post- treatment
时间窗: 8 weeks
TMS-EEG will be recorded pre- and post- treatment by physician and the electroencephalogram (EEG) data will be analyzed with TMS evoked potential by technician, finally, the amplitude change between pre- and post- treatment will be obtained.
functional magnetic resonance images brain functional connection change between pre- and post- treatment
时间窗: 2 weeks
Functional magnetic resonance images (fMRI) will be recorded pre- and post- treatment within 24h. Brain functional connection will be analyzed through fMRI by technician and the change of brain functional connection will be obtained.
diffusion tensor imaging fiber connectivity change between pre- and post- treatment
时间窗: 12 weeks
Diffusion tensor imaging (DTI) will be recorded pre-treatment and post-treatment in three months. DTI data will be analyzed by technician and the change of fiber connectivity change will be obtained.
次要结局
未报告次要终点