Long Term Efficacy and Safety of Transcranial Magnetic Stimulation Targeting Cerebellum to Treat Drug-resistant Epilepsy During Enhanced and Maintenance Phase
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- seizure reduction rate
研究概览
简要总结
This study aims to observe the long term efficacy and safety of cerebellar continuous θ burst stimulation (cTBS) for drug-resistant Epilepsy during enhanced and maintenance phase，in order to provide a new treatment for long-term control of drug-resistant epilepsy and improve the quality of life of those patients. A total of 100 patients with DRE will undergo cTBS treatment by precise navigation to bilateral cerebellar dentate nuclei. The frequency and clinical feature of seizures, scalp EEG，clinical score, MOCA，MMSE，and QOLIE-31 were ssessed at baseline, after 2 weeks of enhanced phase，8 weeks of consolidate phase, and 8 weeks of maintenance phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years old，
- •Participants who are diagnosed as drug- resistant epilepsy,
- •Participants who has a history of DRE ≥2 years before enrollment，
- •Participants who has a seizure frequency of ≥2 seizures every month within 3 months before enrollment,
- •Participants and their families are aware of this study and sign informed consent.
排除标准
- •Participants who are in status epilepticus,
- •Participants who are complicated with serious infection, cerebrovascular disease, malignant tumor and other nervous system diseases, with serious dysfunction of heart, liver, kidney and other organs, and with psychiatric disorders,
- •Participants plan invasive therapy, such as operation,
- •Participants who are in pregnancy or lactating,
- •Patients cannot tolerate repeated transcranial magnetic stimulation, or have contraindications of repeated transcranial magnetic stimulation.
研究组 & 干预措施
Participant Group
Continuous θ-burst stimulation (cTBS) is characterized by plexus stimulation. The stimulation intensity was 80% resting motor threshold (RMT) at 50Hz of intra plexus pulse while the frequency of inter plexus pulse is 5Hz, the duration was 40s, and the number of stimulation pulses was 600. Two groups of stimulation were repeated in each cerebellar dentate nucleus with an interval of 5 min in each group.
干预措施: cTBS (Device)
结局指标
主要结局
seizure reduction rate
时间窗: Enhanced phase: 2 weeks;Consolidation phase：8 weeks; Maintenance phase：8 weeks; Follow up phase：8 weeks
A 28-day baseline for seizure frequency will be recorded by the patients themselves or their guardian before therapy and then compare to the frequency after enhanced phase /consolidation/maintenance treatment / 8 weeks after the end of all treatment
responder rate
时间窗: Enhanced phase: 2 weeks;Consolidation phase：8 weeks; Maintenance phase：8 weeks; Follow up phase：8 weeks
proportion of people with a 50% or greater reduction in seizure frequency following enhanced phase /consolidation/maintenance treatment / 8 weeks after the end of all treatment
次要结局
- MoCA(Enhanced phase: 2 weeks;Consolidation phase：8 weeks; Maintenance phase：8 weeks; Follow up phase：8 weeks)
- QOLIE-31 scale scores(Enhanced phase: 2 weeks;Consolidation phase：8 weeks; Maintenance phase：8 weeks; Follow up phase：8 weeks)
- scalp electroencephalogram(Enhanced phase: 2 weeks;Consolidation phase：8 weeks; Maintenance phase：8 weeks; Follow up phase：8 weeks)
- MRI(Enhanced phase: 2 weeks;Consolidation phase：8 weeks; Maintenance phase：8 weeks; Follow up phase：8 weeks)
- MMSE(Enhanced phase: 2 weeks;Consolidation phase：8 weeks; Maintenance phase：8 weeks; Follow up phase：8 weeks)