NCT01007136终止不适用
TDCS-enhanced Stroke Recovery and Cortical Reorganization
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Upper Extremity Fugl-Meyer
研究概览
简要总结
The purpose is to determine whether application of a non-invasive battery powered device called transcranial direct current stimulation (tDCS) can improve recovery of hand weakness after stroke beyond what is achievable with rehabilitative treatment alone.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ischemic stroke causing arm weakness within 5-15 days
- •no other neurological or psychiatric disease, who are able to perform study tasks
排除标准
- •patients younger than 18 or older than 80 years
- •patients with more than one disabling stroke
- •Patients with bilateral motor impairment
- •Patients with poor motivational capacity, history of severe alcohol or drug abuse
- •Patients with severe language disturbances, particularly of receptive nature
- •Patients with serious cognitive deficits (defined as equivalent to a MMS score of 23 or less)
- •Patients with severe uncontrolled medical problems (e.g., seizures, progressive stroke syndromes, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer or renal disease, end-stage pulmonary or cardiovascular disease, or a deteriorated condition due to age or others),
- •Patients with unstable thyroid disease
- •Patients with increased intracranial pressure
- •Patients with unstable cardiac arrhythmia
- •Patients with contraindication to TMS or tDCS stimulation (pacemaker, an implanted medication pump, a metal plate in the skull, or metal objects inside the eye or skull, patients who had a craniotomy, skin lesions at the site of stimulation)
- •Patients who are not available for follow-up at 3 and 12 months
- •Pregnancy
- •Patients with contraindication to MRI will not participate in MRI
结局指标
主要结局
Upper Extremity Fugl-Meyer
时间窗: 1 year after stroke
Motor outcome measure for the upper extremity. Scores vary between 0-66, higher values mean better performance.
次要结局
- Wolf Motor Function Test(3 months)
研究者
Timea Hodics
Assistant Professor
University of Texas Southwestern Medical Center
研究点 (2)
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