Status:
COMPLETED
The Effects of L-carnitine on Fatigue in Spinal Cord Injury
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Spinal Cord Injury (SCI)
Eligibility:
All Genders
19-65 years
Phase:
PHASE2
Brief Summary
1. Purpose: To explore the use of L-Carnitine, a pharmaceutical product, for the treatment of fatigue in persons with spinal cord injury (SCI). 2. Hypothesis: Similar to previous research in disabled ...
Detailed Description
This is a non-concurrent, multiple baseline single subject research design. This pilot study will treat 4 SCI subjects with L-Carnitine, and track the progress of their fatigue prior to, during and fo...
Eligibility Criteria
Inclusion
- Spinal Cord Injury: paraplegia or tetraplegia (ASIA A, B or C)
- More than 1 year since date of injury
- Clinically significant fatigue, determined by a score on the Fatigue Severity Scale greater than or equal to 4
- Between 19 and 65 years of age
- Ability to provide informed consent
Exclusion
- Spinal Cord Injury ASIA D, or lack of Spinal Cord Injury
- Acute phase of rehabilitation: less than 1 year since date of injury
- Fatigue Severity Scale score less than 4
- Under 19 years of age or above 65 years of age
- Inability to provide informed consent
- Lack of proficiency in English, specified by an inability to read/understand consent form and complete tools
- Inability to come to GF Strong for 4 separate visits
- On-going treatment with anticoagulants such as warfarin or acenocoumarol
- Pregnancy, lactation or breast feeding
- History of seizures
- Hypothyroidism
- Severe liver or kidney disease
- Other on-going fatigue treatment over the past 6 months
- On-going treatment with L-carnitine
- Lack of stability on pain or depression medication over the past 6 months, determined by history. The subjects will be asked about any changes in pain or depression medications over the past 6 months. If they have had a change in pain or depression medications or started a new pain or depression medication within the past 6 months, they will be excluded from the study. Subjects will be asked about their use of supplements and the indications for the supplements. Again, a change in supplements used for pain or depression in the past 6 months will result in exclusion from the study.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01232907
Start Date
October 1 2010
End Date
April 1 2013
Last Update
October 8 2014
Active Locations (1)
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1
Rehab Research Lab, GF Strong Rehab Centre, 4255 Laurel Street
Vancouver, British Columbia, Canada, V5Z 2G9