Phase 2 Study of rTMS on Poststroke Dysphagia
试验速览
- 阶段
- 2 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Dysphagia severity on Aus TOMs swallowing score
研究概览
简要总结
Dysphagia is one of severe complications among stroke survivors. Dysphagia is usually associated with high levels of morbidity, mortality, and financial cost. In recent years, repetitive transcranial magnetic stimulation (rTMS) has shown promise to facilitate poststroke dysphagia. However, most researches were preliminary studies in the past. The present study aims to investigate the immediate and long-term efficacy of high frequency rTMS on chronic dysphagic patients.
详细描述
rTMS protocol: 5 Hz real or sham stimulation, 10 minutes per day, for 10 week-days.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Poststroke dysphagia more than 3 months
排除标准
- •Hx of seizure or a metalic device in brain or chest
研究组 & 干预措施
sham 5 Hz rTMS
sham 5Hz rTMS, 10 minutes per day, for 10 weekdays.
干预措施: rTMS, Magstim Rapid2 (Device)
Real 5 Hz rTMS
real 5 Hz rTMS, 10 minutes per day, for 10 weekdays.
干预措施: rTMS, Magstim Rapid2 (Device)
结局指标
主要结局
Dysphagia severity on Aus TOMs swallowing score
时间窗: up to 3 months
次要结局
- Imaging evidence with video-esophagography(up to 3 months)
研究者
vghtpe user
Po-Yi Tsai, MD
Taipei Veterans General Hospital, Taiwan