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

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

First Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

China Spinal Cord Injury Network

Network

Collaborators

The University of Hong Kong

Registry information

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2009
First posted: Jan 14, 2008
Registry last updated: Jul 3, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed