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

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

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injuries

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • 301 Orthopedic Hospital
  • Chongqing, China
    • Second Affiliated Hospital of Third Military Medcial University
  • Fujian
    • Fuzhou, Fujian, China
      • First Affiliated Hospital of Fujian Medical University
• Taiwan
  • Hualien, Taiwan
    • Buddhist Tzu Chi General Hospital
  • Taichung, Taiwan
    • China Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Hospital

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: China Spinal Cord Injury Network
• Collaborators: The University of Hong Kong
• Investigators: Study Director: Wise Young, MD, PhD, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: January 2, 2008
• First Submitted That Met QC Criteria: January 2, 2008
• First Posted (Estimate): January 14, 2008

Study Record Updates

• Last Update Posted (Estimate): July 3, 2009
• Last Update Submitted That Met QC Criteria: July 2, 2009
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: CN100b