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

This study has been completed.
Sponsor:
Collaborator:
The University of Hong Kong
Information provided by:
China Spinal Cord Injury Network
ClinicalTrials.gov Identifier:
NCT00592722
First received: January 2, 2008
Last updated: July 2, 2009
Last verified: July 2009
  Purpose

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
Spinal Cord Injuries

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multi-Centre Clinical Study in Chronic Spinal Cord Injury Patients

Resource links provided by NLM:


Further study details as provided by China Spinal Cord Injury Network:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: December 2007
Study Completion Date: March 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Director, Clinical Trial Centre, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT00592722     History of Changes
Other Study ID Numbers: CN100b
Study First Received: January 2, 2008
Last Updated: July 2, 2009
Health Authority: China: Ethics Committee
Taiwan: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 25, 2014