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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00592722
Recruitment Status : Completed
First Posted : January 14, 2008
Last Update Posted : July 3, 2009
Sponsor:
Collaborator:
Information provided by:

Study Description
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

Condition or disease
Spinal Cord Injuries

Study Design

Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multi-Centre Clinical Study in Chronic Spinal Cord Injury Patients
Study Start Date : December 2007
Primary Completion Date : December 2008
Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  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 [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospital
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00592722


Locations
China, Fujian
First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
China
301 Orthopedic Hospital
Beijing, China
Second Affiliated Hospital of Third Military Medcial University
Chongqing, China
Taiwan
Buddhist Tzu Chi General Hospital
Hualien, Taiwan
China Medical University Hospital
Taichung, Taiwan
Sponsors and Collaborators
China Spinal Cord Injury Network
The University of Hong Kong
Investigators
Study Director: Wise Young, MD, PhD The University of Hong Kong
More Information

Responsible Party: Director, Clinical Trial Centre, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT00592722     History of Changes
Other Study ID Numbers: CN100b
First Posted: January 14, 2008    Key Record Dates
Last Update Posted: July 3, 2009
Last Verified: July 2009

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System