The Effects of L-carnitine on Fatigue in Spinal Cord Injury

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

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 and aging populations, the investigators hypothesize that treatment with L-Carnitine will result in a significant improvement of clinical fatigue in spinal cord injury clients, effecting a decrease on the Fatigue Severity Scale (FSS) of 0.5 points or more. The investigators expect to see an effect after approximately three weeks of treatment.

As secondary outcomes, the investigators expect to see positive changes in the Centre for Epidemiologic Studies Depression Scale (CES-D)and Visual Analogue Fatigue (VAS-F) and Visual Analogue Pain (VAS-P) scores, due to a combination of previously demonstrated effects of L-Carnitine directly on pain and depression, and the effects of the potential decrease in fatigue.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of British Columbia
• Collaborator: Canadian Institutes of Health Research (CIHR)

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.