Using Neuroimage and Computational Modeling to Customize High-definition Transcranial Direct Current Stimulation Protocols for Facilitating Hand Function Recovery After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Action Research Arm Test (ARAT)
研究概览
简要总结
Transcranial direct current stimulation (tDCS) had recently been shown having feasibility in modulating cortical excitability transiently during motor training in a noninvasive way. The findings support that tDCS and motor practice can positively promote post-stroke motor learning to improve upper-limb motor recovery after stroke. A randomized controlled trial will be conducted with three groups: HD-tDCS, conventional tDCS and sham HD-tDCS. A 10-session training will be provided to evaluate the effectiveness of transient modulation of cortical excitability through tDCS with clinical assessment scores.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Hemiparesis subsequent to first-ever unilateral stroke for more than 6 months;
- •MCP and PIP finger joints can be extended to 180° passively;
- •Sufficient cognition to follow the experimental instructions
排除标准
- •Severe hand spasticity or hand deformity;
- •History of alcohol or drug abuse or epilepsy;
- •Bilateral brain infarcts;
- •Severe cognitive deficits;
- •Comprehensive aphasia;
- •Contraindications to tDCS
研究组 & 干预措施
Sham HD-tDCS group
The stimulator will be shut down after 30s of stimulation. The patients will feel the initial itching sensation at the beginning in order to evaluate the placebo effect.
干预措施: Sham HD-tDCS group (Device)
HD-tDCS group
Constant current (1mA) will be applied for 20min and the anode will be placed over the defined target area
干预措施: HD-tDCS group (Device)
Conventional tDCS group
Constant current (1mA) will be applied for 20min and the anode will be placed over the standard C3/C4 position
干预措施: Conventional tDCS group (Device)
结局指标
主要结局
Action Research Arm Test (ARAT)
时间窗: 3-month after the 10th session training
The ARAT has total 19 items, divided into 4 categories (grasp, grip, pinch, and gross arm movement). It ranges from 3 to 0 (best to worse).
次要结局
- Fugl-Meyer Assessment (Upper Extremity)(3-month after the 10th session training)
- Magnetic Resonance Imaging(Baseline)
- Wolf Motor Function Test (WMFT)(3-month after the 10th session training)
研究者
Raymond KY Tong
Chairman and Professor
Chinese University of Hong Kong