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

NCT00592722 | Completed

• 1 other identifier: CN100b
• Study Type: observational
• Target: 60
• Locations: 2 countries
• Sites: 5

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

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Hospital

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• China Spinal Cord Injury Network: lead
• The University of Hong Kong: collaborator

Study Sites (5)

First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Location

301 Orthopedic Hospital

Beijing, China

Location

Second Affiliated Hospital of Third Military Medcial University

Chongqing, China

Location

Buddhist Tzu Chi General Hospital

Hualien City, Taiwan

Location

China Medical University Hospital

Taichung, Taiwan

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Wise Young, MD, PhD

  The University of Hong Kong

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: January 2, 2008
• First Posted: January 14, 2008
• Study Start: December 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: March 1, 2009
• Last Updated: July 3, 2009

Record last verified: 2009-07

Locations

TW (2); CN (3)