NCT05142917已完成不适用
The Effect of tDCS Based on Functional Brain Imaging for Subacute Stroke Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 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
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)
研究者
研究点 (2)
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