A Multi-Centre Clinical Study in Chronic Spinal Cord Injury Patients
This study has been completed.
Sponsor:
China Spinal Cord Injury Network
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
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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:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
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 Spinal Cord Diseases Central Nervous System Diseases |
Nervous System Diseases Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on June 18, 2013