Motor Excitability Study of High Definition Transcranial Direct Current Stimulation (HD-tDCS) in Chronic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Action Research Arm Test (ARAT)
研究概览
简要总结
High definition tDCS will be conducted to both stroke and healthy subjects on primary motor cortex area to explore the motor excitability changes before and after stimulation. In next stage, a randomized control trial with 20-session training will be conducted to evaluate the effectiveness of transient modulation of cortical excitability through multisite HD-tDCS with EMG driven robot hand training, a sham stimulation with EMG-driven robot hand training will be applied as control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •Sufficient cognition to follow simple instructions, as well as understand the content and purpose of the experiment;
- •Have moderate to severe motor disability at the paretic upper limb (assessed by Fugl-Meter Assessment (FMA), and Action Research Arm Test (ARAT));
- •Hemiparesis resulting from a single unilateral lesion of the brain with onset at least 6 months before data collection
排除标准
- •Severe hand spasticity, open hand wound or hand deformity;
- •Visual field deficits;
- •Aphasia, neglect, and apraxia;
- •History of alcohol, drug abuse or epilepsy;
- •Bilateral infracts;
- •Uncontrolled medical problems;
- •Serious cognitive deficits [Mini-Mental State Examination (MMSE) < 21];
- •Major depression
- •Metal implants inside body
- •MRI, TMS and tDCS contraindications
结局指标
主要结局
Action Research Arm Test (ARAT)
时间窗: Before intervention, After intervention, 6-month after intervention
The ARAT is a 19-item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement) to assess upper limb functioning
Electroencephalography (EEG) and Electromyography (EMG)
时间窗: Before intervention, During intervention, After intervention, 6-month after intervention
It is used to investigate the changes in corticomuscular coherence for studying connectivity between the brainwave using EEG and the affected hand muscles using EMG. In addition, EMG will be used to detect muscle activation change and muscle co-contraction pattern alteration.
Fugl-Meyer Assessment Upper Extremity (FMA-UE)
时间窗: Before intervention, After intervention, 6-month after intervention
It is used to evaluate and measure upper-limb recovery in post-stroke hemiplegic patients, and items are scored on a 3-point ordinal scale
次要结局
- Magnetic Resonance Imaging (MRI)(Before intervention, After intervention, 6-month after intervention)
- Transcranial Magnetic Stimulation (TMS)(Before intervention)
研究者
Raymond KY Tong
Professor
Chinese University of Hong Kong