HOPE From the Cerebellum: TMS-Induced Cognitive Recovery After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- The efficacy of improving cognitive function of post-stroke cognitive impairment
研究概览
简要总结
The objective of this clinical trial is to investigate the effectiveness and safety of repetitive transcranial magnetic stimulation (rTMS) in the cerebellum for individuals with post-stroke cognitive impairment. Participants will undergo rTMS in the cerebellar hemisphere opposite the lesion site, once daily for a total of five days.
详细描述
The primary objective of this clinical trial is to investigate the effectiveness and safety of intermittent theta burst stimulation ( iTBS) in the cerebellum for individuals with post-stroke cognitive impairment. The trial aims to answer two main questions: (1) What is the effectiveness of iTBS in improving post-stroke cognitive impairment? (2) Is iTBS in the cerebellum safe for individuals with post-stroke cognitive impairment? Participants will undergo iTBS in the cerebellar opposite the lesion site, twice daily for five days. The control group will receive sham rTMS with the same parameters and positions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1)ischemic stroke, with an initial incident occurring within 2 weeks;(2)MoCA<26;
排除标准
- •(1)Cerebral hemorrhage or subarachnoid hemorrhage;(2)A pre-existing history of epilepsy;
研究组 & 干预措施
control group
shame stimulation on the contralesional cerebellum
干预措施: control group (Device)
iTBS group
iTBS on the contralesional cerebellum
干预措施: iTBS group (Device)
结局指标
主要结局
The efficacy of improving cognitive function of post-stroke cognitive impairment
时间窗: 3 months follow-up after treatment
The change of MoCA between baseline and 3 months follow-up
次要结局
- The safety of improving cognitive function of post-stroke cognitive impairment(day1-day7)
研究者
Zi-Xiao Li
Dr.
Beijing Tiantan Hospital