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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00592722

Enrollment

Registered

2008-01-14

Start date

2007-12-31

Completion date

2009-03-31

Last updated

2009-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injuries

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Countries

China, Taiwan

Outcome results