ChiCTR-TRC-14005009进行中（未招募）4 期
體外反搏與經顱磁刺激聯合療法對中風病人手部運動功能康復的研究
Division of Neurology, Dept of Medicine and Therapeutics, PWH, The Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2014年9月20日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- upper limb Fugl-Meyer Assessment (FMA)
研究概览
简要总结
體外反搏與經顱磁刺激聯合療法對中風病人手部運動功能康復
研究设计
- 研究类型
- 干预性研究
- 主要目的
- 随机平行对照
入排标准
- 年龄范围
- 18 至 80（—）
- 性别
- All
入选标准
- •patients aged 18 or above;
- •first-ever ischemic subcortical stroke with onset time less than 21 days;
- •hand weakness (distal MRC 1- 5-) as a result of stroke;
- •recordable MEPs over ipsilesional hemisphere;
- •intracranial hemorrhage excluded by brain computed tomography (CT) / magnetic resonance imaging (MRI);
- •the patient or his/her legally acceptable representative is willing to provide written informed consent.
排除标准
- •personal history of epilepsy;
- •metallic implants in any part of body;
- •implanted cardiac pacemaker, defibrillator, medication pump or any other implanted electronics;
- •severe skull fracture, serious head injury, history of brain or spinal cord surgery;
- •brain tumour or other significant non-ischemic brain lesion on CT/MRI;
- •administration of drugs that potentially lower seizure threshold;
- •active malignancy;
- •severe co-existing systemic diseases: eg. renal failure (creatinine more than 300 umol/L, if known), cirrhosis, severe dementia or psychosis;
- •inability to be followed up at regular interval;
- •pegnancy or breast-feeding.
- •evidence for cardioembolic stroke such as atrial fibrillation and rheumatic heart disease;
- •sustained hypertension (systolic higher than 180mmHg or diastolic higher than 100mmHg);
- •subject has thrombocytopenia (platelet count less than 100,000/mm3);
- •evidence of arteriovenous malformation, arteriovenous fistula or aneurysm;
- •evidence of diabetic retinopathy.
研究组 & 干预措施
Two groups
Device transcranial magnetic stimulation & enhanced external conterpulsation 10 sessions for TBS and EECP versus 10 sessions of sham therapy
结局指标
主要结局
upper limb Fugl-Meyer Assessment (FMA)
时间窗: at 90 days after intervention
次要结局
- FMA, National Institutes of Health Stroke Scale (NIHSS), modified-Rankin Scale (mRS);(at baseline (1 day), 10 days or last session of therapy and 90 days after intervention)
- grip strength, lateral pinch grip, purdue pegboard test;(at baseline (1 day), 10 days or last session of therapy and 90 days after intervention)
- TMS measures including RMT, AMT, MEPs(at baseline (1 day), 10 days or last session of therapy and 90 days after intervention)
研究者
研究点 (1)
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