Individualized Brain Stimulation Using Transcranial Direct Current Stimulation Simulation in Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Changes in motor evoked potential
研究概览
简要总结
This study is to investigate the effect of transcranial direct current stimulation (tDCS) simulation-based individualized stimulation compared to conventional stimulation and 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 patients
- •Chronic patients over 6 months after onset
- •Patients with motor evoked potential of the first dorsal interosseous muscle
- •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
结局指标
主要结局
Changes in motor evoked potential
时间窗: Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions)
Resting motor threshold (rMT), amplitude, and latency of motor evoked potential in the first dorsal interosseous muscle are measured. These outcomes are measured by transcranial magnetic stimulation over the motor hotspot. The rMT is defined as the minimum stimulus intensity that produced a minimal motor evoked response at rest. The amplitude means peak to peak of the muscle response. The latency is defined as the time point from the onset of the stimulus to the onset of MEP.
次要结局
- Jebsen-Taylor hand function test(Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions))
- 9-hole peg test(Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions))
- Grip & Tip pinch strength test(Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions))
- Box & Block test(Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions))
- Fugl-Meyer Assessment(Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions))
- Sequential motor test(Baseline, 1 day (immediately after one brain stimulation session), 5 days (immediately before and after three brain stimulation sessions), and about 14 days (immediately before and after five brain stimulation sessions))
研究者
Yun-Hee Kim
Professor
Samsung Medical Center