NCT00592722已完成不适用
A Multi-Centre Clinical Study in Chronic Spinal Cord Injury Patients
China Spinal Cord Injury Network5 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2007年12月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 5
- 主要终点
- The primary study outcomes will be the subject recruitment rate, the subject drip out rate, the number of missing values and the number of submitted incorrect values
研究概览
简要总结
To establish a solid foundation, e.g. network and a coordinating centre for testing new SCI therapies in forthcoming randomized controlled multi-centre clinical trials following international standards and guidelines
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female adult subjects, 18 to 60 years of age;
- •Have a clinical diagnosis of chronic SCI (defined as a history of ≥ 12 months suffering SCI);
- •The diagnosis of SCI was confirmed by MRI; and
- •Voluntarily signs and dates an Informed Consent Form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), prior to any study-specific procedures
排除标准
- •Severe head injury;
- •Is medically or mentally unstable according to the judgement of the Investigator;
- •History of Multiple Sclerosis or peripheral demyelinating disease;
- •Likely to have experimental therapy;
- •Any criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol
结局指标
主要结局
The primary study outcomes will be the subject recruitment rate, the subject drip out rate, the number of missing values and the number of submitted incorrect values
时间窗: 6 months
次要结局
未报告次要终点
研究者
研究点 (5)
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