A Randomized, Double-Blind, Sham-Controlled, Multi-center Clinical Trial to Evaluate Efficacy and Safety of rTMS 『TMS』 for Upper Extremity Motor Function Recovery in Patients With Ischemic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 6
- 主要终点
- Box and Block Test (affected hand)
研究概览
简要总结
The purpose of this study is to Evaluate Efficacy and Safety of rTMS 『TMS』 for Upper Extremity Motor Function Recovery in Patients with Ischemic Stroke
详细描述
Repetitive transcranial magnetic stimulation (rTMS) can modulate the excitability of cortex but exact efficacy and safety of rTMS is not well established.
Eighty four patients will be recruited and will be divided into two groups. Each group will receive the real rTMS or sham rTMS, respectively, over the primary motor cortex of the dominant hand. Individual subject will receive ten sessions of rTMS. Each rTMS session is low frequency (1Hz), total 1800 stimulations.
The purpose of this study is to evaluate efficacy and safety of rTMS 『TMS』 for upper extremity motor function recovery in patients with ischemic stroke.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20-80 yrs old
- •Radiologically confirmed ischemic stroke within 90 days
- •Brunnström stage 3-5 in the affected hand (ischemic stroke-induced hemiplegic side)
- •Patients received stroke treatment and on secondary prevention medication
- •Written informed consent
排除标准
- •Previous medical histories of stroke, cerebral vascular operation, seizure
- •Pregnancy, Breastfeeding
- •Patients with hemorrhagic stroke, traumatic brain injury
- •Skin lesion in the stimulation site of scalp
- •Metal implants in the body (cardiac pacemaker or aneurysm clip)
- •Unable to have regular physical and occupational therapies on the affected hand
结局指标
主要结局
Box and Block Test (affected hand)
时间窗: up to 17 days
Before rTMS (baseline) and 10 days after the completion of 10 sessions of rTMS
次要结局
- Barthel Index(up to 40 days)
- Box and Block Test (Affected and unaffected hand)(up to 40 days)
- Finger tapping(up to 40 days)
- Modified Ashworth scale (wrist flexor and extensor, Elbow flexor and extensor, Long finger flexor spasticity)(up to 40 days)
- National Institutes of Health Stroke Scale(up to 40 days)
- Grip strength (hand grip, pinch grip, lateral prehension, three jaw chuck)(up to 40 days)
- B-stage (hand and arm)(up to 40 days)
- Fugl-Meyer Assessment Scale(up to 40 days)
研究者
Nam-Jong Paik
Professor
Seoul National University Bundang Hospital