Investigation of Compensational Mechanism and Effect of Transcranial Direct Stimulation on Motor Learning Through Neural Network Analysis in Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Fugl-Meyer Assessment
研究概览
简要总结
This study is to investigate the effect of transcranial direct current stimulation (tDCS) simulation on motor learning to stroke patients compared to sham stimulation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral stroke including basal ganglia lesion patients
- •Chronic patients over 6 months after onset
- •Patients with the movement of fingers
排除标准
- •History of psychiatric disease
- •Significant other neurological diseases except for stroke
- •Difficult to perform this experiment
- •Patients who are deemed difficult to participate in this research by the investigator
- •Patients with metal implants and medical devices
- •History of epilepsy
- •Pregnancy
- •Skin defect at the site of electrode attachment
研究组 & 干预措施
Real stimulation before motor learning training
Patients receive five sessions of tDCS stimulation over C3 (patient with left-sided lesion) or C4 (patient with right-sided lesion) based on 10-20 system immediately before sequential finger tapping task.
干预措施: Transcranial Direct Current Stimulation (Device)
Real stimulation before motor learning training
Patients receive five sessions of tDCS stimulation over C3 (patient with left-sided lesion) or C4 (patient with right-sided lesion) based on 10-20 system immediately before sequential finger tapping task.
干预措施: Motor learning (Behavioral)
Sham stimulation before motor learning training
Patients receive five sessions of sham stimulation over C3 (patient with left-sided lesion) or C4 (patient with right-sided lesion) based on 10-20 system immediately before sequential finger tapping task.
干预措施: Motor learning (Behavioral)
结局指标
主要结局
Fugl-Meyer Assessment
时间窗: Baseline, immediately after five brain stimulation sessions
The score is a stroke-specific, performance-based impairment index. The degree of impairment of upper and lower limbs is measured.
次要结局
- Changes in cortical activity using fNIRS signals during brain stimulation(Baseline, during, immediately after five brain stimulation sessions)
- Box & Block test(Baseline, immediately after five brain stimulation sessions)
- Grip & Tip pinch strength test(Baseline, immediately after five brain stimulation sessions)
- Sequential Finger tapping test(Baseline, immediately after five brain stimulation sessions)
- 9-hole pegboard test(Baseline, immediately after five brain stimulation sessions)
- Changes in motor evoked potential(Baseline, immediately after five brain stimulation sessions)
- Jebsen-Taylor hand function test(Baseline, immediately after five brain stimulation sessions)
研究者
Yun-Hee Kim
Principal Investigator
Samsung Medical Center