Overview

Acetyl-l-carnitine to Enhance Nerve Regeneration in Carpal Tunnel Syndrome

Status:
Completed
Trial end date:
2017-09-01
Target enrollment:
0
Participant gender:
All
Summary
Study Hypothesis: Acetyl-l-carnitine increases nerve regeneration in patients with severe carpal tunnel syndrome. Carpal tunnel syndrome (CTS) is common, affecting almost 3% of the general population. In severe cases, nerve regeneration and functional recovery are incomplete even with surgery. The goal of this pilot project is to test a potentially promising medication, acetyl-l-carnitine (ALCAR). We will use a randomized, double blinded, placebo controlled study design. Along with surgery, those in the treatment group will also receive ALCAR while the other half in the control group will be given placebo. To gauge the effects of ALCAR, we will compare motor and sensory nerve growth as well as functional outcomes. The data from this study will provide crucial information when designing a full scale clinical trial. If successful, this will represent an important first step in finding a novel treatment to improve functional outcomes in patients with severe CTS.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Alberta
Treatments:
Acetylcarnitine
Criteria
Inclusion Criteria:

- Patients will be recruited from the University of Alberta Hospital referred for CTS.
Inclusion criteria will include adult patients (over age 18) with at least one of the
following symptoms:

1. numbness and parenthesis in the median nerve distribution;

2. Precipitation of those symptoms by repetitive motions that are relieved by
rubbing and or shaking the hands;

3. Nocturnal awakening by those sensory symptoms, or

4. Weakness of thumb abduction and thenar atrophy.

Exclusion Criteria:

1. Motor unit loss in the median nerve less than 2 SD below the mean for the age as
determined by nerve conduction studies.

2. The presence of other neurologic conditions

3. Previous carpal tunnel release surgery

4. Cognitive impairment that renders the patient unable to provide informed consent;

5. Pregnancy