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【ChiCTR-TRC-14005009】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

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基本信息

登记号

ChiCTR-TRC-14005009

试验状态

正在进行

药物名称

药物类型

规范名称

首次公示信息日的期

2014-07-25

临床申请受理号

靶点

适应症

stroke

试验通俗题目

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

试验专业题目

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

申办单位信息

申请人联系人

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申请人名称

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联系人邮箱

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联系人邮编

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临床试验信息

试验目的

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

试验分类

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试验类型

随机平行对照

试验分期

Ⅳ期

随机化

RCT

盲法

试验项目经费来源

Division of Neurology, Dept of Medicine and Therapeutics, PWH, The Chinese University of Hong Kong

试验范围

目标入组人数

实际入组人数

第一例入组时间

2014-09-20

试验终止时间

1990-01-01

是否属于一致性

入选标准

1) patients aged 18 or above; 2) first-ever ischemic subcortical stroke with onset time less than 21 days; 3) hand weakness (distal MRC 1- 5-) as a result of stroke; 4) recordable MEPs over ipsilesional hemisphere; 5) intracranial hemorrhage excluded by brain computed tomography (CT) / magnetic resonance imaging (MRI); 6) the patient or his/her legally acceptable representative is willing to provide written informed consent.；

排除标准

For TMS : 1) personal history of epilepsy; 2) metallic implants in any part of body; 3) implanted cardiac pacemaker, defibrillator, medication pump or any other implanted electronics; 4) severe skull fracture, serious head injury, history of brain or spinal cord surgery; 5) brain tumour or other significant non-ischemic brain lesion on CT/MRI; 6) administration of drugs that potentially lower seizure threshold; 7) active malignancy; 8) severe co-existing systemic diseases: eg. renal failure (creatinine more than 300 umol/L, if known), cirrhosis, severe dementia or psychosis; 9) inability to be followed up at regular interval; 10) pegnancy or breast-feeding. For ECP: 11) evidence for cardioembolic stroke such as atrial fibrillation and rheumatic heart disease; 12) sustained hypertension (systolic higher than 180mmHg or diastolic higher than 100mmHg); 13) subject has thrombocytopenia (platelet count less than 100,000/mm3); 14) evidence of arteriovenous malformation, arteriovenous fistula or aneurysm; 15) evidence of diabetic retinopathy.；

研究者信息

研究负责人姓名

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试验机构

Medicine & Therapeutics, The Chinese University of Hong Kong

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研究负责人邮编

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