A Multi-Centre Clinical Study in Chronic Spinal Cord Injury Patients

Completed

• Conditions: Spinal Cord Injuries

• Registration Number: NCT00592722
• Lead Sponsor: China Spinal Cord Injury Network

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-01-02
• Study First Submitted QC: 2008-01-02
• Study First Posted: 2008-01-14
• Primary Completion: 2008-12
• Study Completion: 2009-03
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-02
• Last Update Posted: 2009-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Male or female adult subjects, 18 to 60 years of age;
2. Have a clinical diagnosis of chronic SCI (defined as a history of ≥ 12 months suffering SCI);
3. The diagnosis of SCI was confirmed by MRI; and
4. 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

Exclusion Criteria

1. Severe head injury;
2. Is medically or mentally unstable according to the judgement of the Investigator;
3. History of Multiple Sclerosis or peripheral demyelinating disease;
4. Likely to have experimental therapy;
5. Any criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	6 months

Trial Locations

Locations (5)

First Affiliated Hospital of Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China

China Medical University Hospital; 🇨🇳 Taichung, Taiwan

Buddhist Tzu Chi General Hospital; 🇨🇳 Hualien, Taiwan

Second Affiliated Hospital of Third Military Medcial University; 🇨🇳 Chongqing, China

301 Orthopedic Hospital; 🇨🇳 Beijing, China