Prediction of Transcranial Direct Current Stimulation (tDCS) Responses Using Electroencephalography (EEG )in Patients With Chronic Stroke
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Changes in Fugl-Meyer Assesment Score 1
研究概览
简要总结
Patients with chronic stroke (>6 months after stroke) having unilateral upper limb hemiparesis will be recruited. Patients will maintain their usual inpatient rehabilitation including occupational therapy. At baseline (T0) and after 2weeks of enrollment (T1), Fugl-Meyer assessment (FMA) will be assessed at each time. And patients with the changes of FMA between T0 and T1 less than 3 points will be finally recruited. The enrolled patients will receive additional 30-min cathodal transcranial direct current stimulation (tDCS) over the contralesional motor cortex for 10 consecutive weekdays, with maintaining their usual conventional rehabilitation. At T1 and immediately after 10-seessions of tDCS (T2) and 1 month after completing 10-tDCS session (T3), FMA, Actional Research Arm Test (ARAT), Box and Block Test (BBT) and electroencephalography (EEG) were measured.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ranges from 19 to 85 yrs old
- •stroke patients with unilateral hemiparesis
- •1st ever stroke
- •chronic stroke (>6 months after stroke)
排除标准
- •recurrent stroke
- •history of traumatic brain injury
- •Minimental state examination score is 15 or less.
- •Unstable medical conditions
- •Severe delirium, disorders of consciousness
- •pregnancy
- •can not attach tDCS electrode on the scalp due to skin conditions
- •can not maintain the sitting position
- •intracranial metals
结局指标
主要结局
Changes in Fugl-Meyer Assesment Score 1
时间窗: Between T1 (before tDCS) and T2 (immediately after completing 10 sessions of tDCS)
次要结局
- Changes in Fugl-Meyer Assesment Score 2(Between T2 (immediately after completing 10 sessions of tDCS) and T3 (1 month after completing 10 sessions of tDCS))
- Changes in Action Research Arm Test Score 1(Between T1 (before tDCS) and T2 (immediately after completing 10 sessions of tDCS))
- Changes in Box and Block Test Score 1(Between T1 (before tDCS) and T2 (immediately after completing 10 sessions of tDCS))
- Changes in Box and Block Test Score 2(Between T2 (immediately after completing 10 sessions of tDCS) and T3 (1 month after completing 10 sessions of tDCS))
- Changes in Action Research Arm Test Score 2(Between T2 (immediately after completing 10 sessions of tDCS) and T3 (1 month after completing 10 sessions of tDCS))
- Changes in EEG index1(Between T1 (before tDCS) and T2 (immediately after completing 10 sessions of tDCS))
- Changes in EEG index 2(Between T2 (immediately after completing 10 sessions of tDCS) and T3 (1 month after completing 10 sessions of tDCS))
研究者
Won-Seok Kim
Associate professor
Seoul National University Bundang Hospital