Bilateral Continuous Theta Burst Stimulation of Cerebellum for Drug-refractory Epilepsy: A Double Blind, Randomised, Single Centre, Crossover Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- responder rate
研究概览
简要总结
This study aims to observe the effect and safety of cerebellar continuous θ burst stimulation (cTBS) for drug-refractory epilepsy(DRE), in order to provide a new treatment for DRE and improve the quality of life of those patients. A total of 44 patients with DRE will have cTBS via accurate navigation to bilateral cerebellar dentate nuclei. Patients will be randomised into 2 groups in a crossover trial design to have 2 week periods of cTBS separated by 8 week washout periods, following which the patient will cross over to have the opposite condition for a further 2 week. Frequency and symptoms of seizures, scalp EEG, clinical scores, and QOLIE-31 were assessed at baseline and after 1 and 2 month of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •a) Participants who are in line with the diagnostic criteria for epilepsy,
- •b) Participants who are diagnosed as drug-refractory epilepsy,
- •c) Participants who has duration of epilepsy ≥2 years and seizure frequency ≥2 times per month,
- •d) The type and dosage of anti-epileptic drugs do not change during the experiment,
- •e) Participants or their families reject invasive therapy, such as operation,
- •f) Participants and their families are aware of this study and sign informed consent.
排除标准
- •a) Participants who are in status epilepticus,
- •b) 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,
- •c) Participants who are diagnosed as syncope, hysteria or other non-epileptic attacks,
- •d) Participants who are in pregnancy or lactating,
- •e) Participants who have incomplete clinical data,
- •f) Patients have contraindications of repeated transcranial magnetic stimulation.
结局指标
主要结局
responder rate
时间窗: 8 weeks
proportion of people with a 50% or greater reduction in seizure frequency following the treatment period
seizure reduction rate in pre- and post-treatment
时间窗: 8 weeks
A 28-day baseline for seizure frequency will be recorded by the patients themselves or their relatives before therapy and then compare to the frequency at 4-week and 8-week after treatment, finally, the rate of reduction in seizure frequency was obtained
次要结局
- IQ(8 weeks)
- MoCA(8 weeks)
- MMSE(8 weeks)
- HAMA(8 weeks)
- QOLIE-31 scale scores(8 weeks)
- HAMD(8 weeks)
- scalp electroencephalogram(8 weeks)
- SCL-90(8 weeks)
- MQ(8 weeks)