The Effect of tDCS Based on Functional Brain Imaging for Subacute Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Changes of score: Fugl-Meyer Assessment
研究概览
简要总结
The purpose of this study is to investigate whether brain imaging-based hand function area tDCS stimulation is more effective than conventional stimulation or sham stimulation for improving hand motor function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 aged 19 to 80 years
- •Patients with subacute stroke within 4 weeks of onset
- •Patients with moderate or severe upper extremity dysfunction with an upper extremity FMA score of less than 58 in motor function evaluation
排除标准
- •Accompanied by an existing serious neurogenic disease
- •Existing significant psychiatric disorders such as major schizophrenia, bipolar disorder, and dementia.
- •If there are difficulties in conducting the research
- •Any patients who are judged by the investigator to be difficult to participate in this study
- •Exclusion criteria for transcranial direct current stimulation:
- •i) Patients with implanted medical devices in the body (e.g. pacemakers) ii) When a metal object is inserted in the skull iii) If there is a wound on the skin of the attachment site iv) history of epilepsy v) Pregnant and lactating women
研究组 & 干预措施
fNIRS based hand motor area real stimulation
Real stimulation is applied to functional brain image-based hand function area (20 minutes) and then hand motor task (20 minutes).
干预措施: Transcranial Direct Current Stimulation (Device)
fNIRS based hand motor area real stimulation
Real stimulation is applied to functional brain image-based hand function area (20 minutes) and then hand motor task (20 minutes).
干预措施: Hand motor task (Behavioral)
Traditional hand motor area real stimulation
Real stimulation is applied to the traditional hand function area (20 minutes) and then hand motor task (20 minutes).
干预措施: Transcranial Direct Current Stimulation (Device)
Traditional hand motor area real stimulation
Real stimulation is applied to the traditional hand function area (20 minutes) and then hand motor task (20 minutes).
干预措施: Hand motor task (Behavioral)
Traditional hand motor area sham stimulation
Sham stimulation is applied to the traditional hand function area (20 minutes) and then hand motor task (20 minutes).
干预措施: Hand motor task (Behavioral)
结局指标
主要结局
Changes of score: Fugl-Meyer Assessment
时间窗: Baseline, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session
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 Box & Block test(Baseline, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session)
- Changes of score: Geriatric Depression Scale-Short Form(Baseline, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session)
- Changes of score: 9-hole pegboard test(Baseline, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session)
- Changes of score: Korean version of Modified Barthel Index(Baseline, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session)
- Changes of score: Korean-Montreal Cognitive Assessment(Baseline, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session)
- Changes of score: Grip & Tip pinch strength test(Baseline, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session)
- Changes of score: Jebsen-Taylor hand function test(Baseline, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session)
- Changes in cortical activity using fNIRS signals(Baseline, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session)