Effects of the Quantity of Repetitive Transcranial Magnetic Stimulation on the Recovery of Upper Motor Function After Stroke: a Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Change in the Fugl-Meyer Assessment scale (upper extremity)
研究概览
简要总结
The aim of this multicentric double blind study (randomized study) is to demonstrate the relationship between the amount of rTMS and the efficacy in the treatment of upper extremity motor deficits of stroke patients.
详细描述
Repetitive transcranial magnetic stimulation (rTMS) can modulate excitability of the brain via non-invasive methods. In that sense, rTMS has been used to treat a variety of symptoms of stroke during last two decades. Especially, improvement of upper extremity function has been proved by many studies. However, it remains uncertain about the optimum amount of rTMS.
The aim of this multicentric double blind study (randomized study) is to demonstrate the relationship between the amount of rTMS and the efficacy in the treatment of upper extremity motor deficits of stroke patients.
Fifty-seven patients will be included with written consent. After randomization, the subject will receive 3 different amount of treatment rTMS-rTMS, Sham-rTMS, Sham-Sham) in double blind methods.
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
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •single mono-hemispheric ischemic or hemorrhagic stroke
- •1st onset stroke patient
- •Upper extremity functional deficit attributable to acute stroke
- •A stage of at least 3 on brunnström pre-treatment
- •Written signed consent
排除标准
- •Multiple lesion
- •Bilateral cortical lesion and motor problems
- •Cerebellar, or brainstem lesions
- •History of more than one stroke
- •Uncontrolled medical problems, such as: cardiopulmonary disease, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer, or renal disease;
- •Increased intracranial pressure
- •History of seizure confirmed by interview and medical chart review
- •Any individual who is on medication which is known to lower seizure threshold
- •Other conditions that increase the risk of side effects due to rTMS procedures: a metal plate or metal object in the skull or eye, intracardiac line, increased intracranial pressure, cardiac pacemaker, implanted medication pump, tricyclic antidepressants, neuroleptics, history of seizure in the immediate family
- •An age of less than 20 years old
- •Any current actively treated medical or surgical condition or neurological or psychiatric illness other than stroke
- •Complications that would prevent participation in the intervention, such as severe pain and severe spasticity
- •Inability to cooperate outcome measure-related task
- •Severe language disturbances
- •Serious cognitive deficits
- •Non-vascular cause for the neurological symptoms other central nervous system
- •Disorder or peripheral neuropathy of the upper extremity
- •Taking medication which interrupt brain activity
- •Women who are pregnant
结局指标
主要结局
Change in the Fugl-Meyer Assessment scale (upper extremity)
时间窗: Baseline, weekly during treatment, at 4-week follow-up,and at 12-week follow-up
次要结局
- Change in grip strength, lateral pinch force, tip pinch force, Purdue pegboard test, K-MBI, mRS,and brunnström stage(Baseline, weekly during treatment, at 4-week follow-up,and at 12-week follow-up)
研究者
Nam-Jong Paik
Professor
Seoul National University Bundang Hospital