Pilot Study of Transcranial Direct Current Stimulation for Facilitating Swallowing Improvement After an Acute Unilateral Hemispheric Infarction
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Dysphagia Outcome and Severity Scale Score (DOSS)
研究概览
简要总结
The purpose of the research study is to investigate the effect of a brain stimulation technique called Transcranial Direct Current Stimulation (TDCS) in improving swallowing functions in subjects who develop dysphagia after a unilateral hemispheric infarction.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute ischemic stroke
- •Between 24-168 hours after onset
- •Moderate to severe dysphagia based on swallowing assessment
排除标准
- •Preexisting swallowing impairment
- •Intracerebral hemorrhage
- •Pacemaker of other electrically sensitive device
研究组 & 干预措施
tDCS
tDCS will provide an increase in cortical excitability. Patients will be randomized to receive tDCS or sham stimulation.
干预措施: tDCS (Other)
sham
Sham stimulation will provide identical subjective sensation as anodal tDCS.
干预措施: Sham (Other)
结局指标
主要结局
Dysphagia Outcome and Severity Scale Score (DOSS)
时间窗: 5 days after study enrollment
DOSS is a validated swallowing assessment scoring system that will rate the severity of dysphagia. It will be performed by a speech and swallow pathologist.
次要结局
- Incidence of seizure(5 days after study enrollment)
研究者
Sandeep Kumar
Assistant Professor of Neurology
Beth Israel Deaconess Medical Center