Phase 2 Study of rTMS Application in Aphasic Patients Evaluated With fMRI
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Concise Chinese Aphasia Test
研究概览
简要总结
The substantial efficacy and the possible mechanism of repetitive transcranial magnetic stimulation (rTMS) improving language recovery remained unclear. It is hypothesized that the rTMS was associated with increased synaptic connection and neural regeneration which can be evaluated via functional neuroimage and neurofiber imaging analysis. The effect of rTMS intervention was monitored by clinical testing and neuroimaging study.
详细描述
2-week rTMS modulation has been proved to produce substantial clinical benefit with sham-controlled study. This trial aimed to investigate the possible mechanism and make clinical correlation.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aphasic stroke in chronic stage (over 3 months)
排除标准
- •No seizure history, no brain surgery history, no electronic device in brain or chest, no dementia
研究组 & 干预措施
1 Hz rTMS, real
1 Hz rTMS over unaffected hemisphere for 15 minutes
干预措施: rTMS (Device)
1Hz rTMS, sham
1Hz sham rTMS, over unaffected hemisphere for 15 minutes
干预措施: rTMS (Device)
结局指标
主要结局
Concise Chinese Aphasia Test
时间窗: Before the rTMS intervention, at 2nd week, and 3rd month
Assess the linguistic skills such as conversation, expression, description, comprehension...
次要结局
- Functional MRI(Before rTMS intervention, and at the day completing the rTMS treatment.)
研究者
vghtpe user
Po-Yi Tsai, MD
Taipei Veterans General Hospital, Taiwan