Effects of Transcranial Direct Current Stimulation on Hemiplegic Upper Extremity Function After Strokes
试验速览
- 阶段
- 不适用
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Fugl-Meyer Upper Motor Score change
研究概览
简要总结
The investigators hypothesize that transcranial direct current stimulation (tDCS) can improve upper limb motor recovery in the sub-acute phase of stroke patients.
This is a randomized, controlled, double blind, cross-over, multicentre, clinical trial.
详细描述
The investigators hypothesize that transcranial direct current stimulation (tDCS) can improve upper limb motor recovery in the sub-acute phase of stroke patients.
This is a randomized, controlled, double blind, cross-over, multicentre, clinical trial.
Informed consent was obtained from all participants and procedures were conducted according to the Declaration of Helsinki. The protocol was approved by the Chonbuk National Uni. Hospital IRB, KOREA.
Seventy-two stroke patients in the sub-acute phase will be recruited in three centers of neurorehabilitation in republic of Korea.
Patients will be randomly divided to four groups; group1 is anodal stimulation on the lesioned primary motor cortex, group 2 is cathodal stimulation on the non-lesioned primary motor cortex, group 3 is dual stimulation such as anodal stimulation on the lesioned side and cathod stimulation on the non-lesioned side, and group 4 is shame stimulation group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral Stroke patients
- •Inclusion must be in the sub-acute phase defined as within 48hr-4 weeks after stroke
- •Patients who have evoked motor potentials on the first dorsal interossei muscles on hemiplegic hand
- •The patient has subscribed the informed consent
排除标准
- •Insert a metal object on the head
- •Convulsive disorders
- •History of brain diseases other than stroke
结局指标
主要结局
Fugl-Meyer Upper Motor Score change
时间窗: before treatment, 48 hours after treatment, 4 weeks after treatment
次要结局
- Range of Motion (ROM) change(before treatment, 48 hours after treatment, 4 weeks after treatment)
- Korean version Modified Bathel Index (KMBI) change(before treatment, 48 hours after treatment, 4 weeks after treatment)
- Manual Muscle Test (MMT) change(before treatment, 48 hours after treatment, 4 weeks after treatment)
研究者
Myoung Hwan Ko
Professor
Chonbuk National University Hospital