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

October 25, 2017 updated by: Ming Chan, University of Alberta

Acetyl-l-carnitine to Enhance Nerve Regeneration in Carpal Tunnel Syndrome; a Randomized Control Trial.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Trial Conduct: This study will be conducted in compliance with the protocol approved by both the University of Alberta Health Research Ethics Board (HREB) and Health Canada. The study will be carried out according to Good Clinical Practice standards. No deviation from the protocol will occur once approved, unless the protocol has put patients at risk. If deviation needs to occur, both HREB and Health Canada will be notified. Written amendments will be submitted to both HREB and Health Canada for their approval.

Population Adult patients suffering from severe CTS would be a population of the interest. Severity of CTS is defined by clinical symptoms and electromyography (EMG) results. These patients will then be recruited for baseline studies, motor unit number estimation (MUNE). Motor unit number estimation is an EMG technique that quantifies the amount of motor units a muscle contains. In various forms of neuropathies, the MUNE decreases. For our study, patients will be included only if their MUNE is 2 standard deviations below normal. These patients will be identified from referrals to plastic surgery clinics or EMG clinics for management.Pre-study Screening and Baseline Evaluation The subject will have a complete physical exam including clinical labs and an ECG. Only those who have normal laboratory and ECG findings will be enrolled in the study.

Randomization Randomization - After enrollment, patients will be randomized to placebo or acetyl-l-carnitine. A statistician will be employed to develop a randomization sequence. Randomization will be kept on a computer under password encryption. The randomization sequence will only be broken if an adverse event occurs to a patient. At the end of the study the statistician will provide the research team with the randomization sequence codes.

Blinding - The study will be administered in a double-blind manner. The randomization sequence will be kept confidential and only accessible to authorized personnel. Pharmacy will distribute identical pills labelled in bottles with A or B. The research team will be unaware of which contains the study drug or placebo. This will be maintained until the final follow-up has occurred when the research team will be unblinded.

Duration The duration of the study is approximately 13 months for each patient. Screening and baseline evaluation will occur within 1 month preoperatively. The investigators will review and document the screening laboratory tests and ECG results. Acetyl-l-carnitine regimen will begin immediately following surgery. This will be continued for 2 months duration. The patient will then complete follow-up visits at 1, 2, 3, 6, and 12 month intervals. At some of those visits, safety monitoring will include periodic blood chemistries, vital signs and evaluation of overall clinical condition (details shown in table above). All clinically relevant changes occurring during the study will be examined and documented. In cases where laboratory abnormalities are detected, appropriate medical management and advice will be provided.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T5H 3V9
        • Royal Alexandra Hospital
      • Edmonton, Alberta, Canada, T5G 0B7
        • Glenrose Hosptial
      • Edmonton, Alberta, Canada, T5R2E1
        • University of Alberta Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acetyl-l-carnitine
Acetyl-l-carnitine will be administered for 2 months duration at a dosage of 3000 mg/d starting at the time of decompression surgery.
Drug: Acetyl-l-carnitine
Those randomized to the treatment arm will receive the medication at 1 g tid for 60 days
Placebo Comparator: Placebo
Placebo will be given for 2 months starting at the time of decompression surgery
Drug: placebo
The control subjects will receive placebo tablets that are identical in appearance and taste to the active medication tid for 60 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in motor unit number estimates
Time Frame: Baseline, 3, 6, and 12 months
An electromyography technique used to quantify the number of motor units in a motor nerve.
Baseline, 3, 6, and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in two point discrimination
Time Frame: Baseline, 3, 6, and 12 months
Measurement of spatial determination
Baseline, 3, 6, and 12 months
Change in pressure sensitivity using Semmes-Weinstein Monofilaments
Time Frame: Baseline, 3, 6, and 12 months
Measurement of pressure sensitivity
Baseline, 3, 6, and 12 months
Change in cold detection threshold
Time Frame: Baseline, 3, 6, and 12 months
Baseline, 3, 6, and 12 months
Change in pain detection thresholds
Time Frame: Baseline, 3, 6, and 12 months
Quantitative measurements of pain thresholds
Baseline, 3, 6, and 12 months
Change in hand dexterity using the Purdue Pegboard
Time Frame: Baseline, 3, 6, and 12 months
Measurement of hand dexterity
Baseline, 3, 6, and 12 months
Change in disability scores using the Disability of Arm, Shoulder and Hand questionnaire
Time Frame: Baseline, 3, 6, and 12 months
Validated questionnaire for functionality in carpal tunnel syndrome
Baseline, 3, 6, and 12 months
Change in hand symptoms using the Levine questionnaire for carpal tunnel syndrome
Time Frame: Baseline, 3, 6, and 12 months
Validated questionnaire for functionality in carpal tunnel syndrome
Baseline, 3, 6, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Investigators

  • Principal Investigator: Ming Chan, MB,ChB, Professor, University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

May 13, 2014

First Submitted That Met QC Criteria

May 14, 2014

First Posted (Estimate)

May 16, 2014

Study Record Updates

Last Update Posted (Actual)

October 27, 2017

Last Update Submitted That Met QC Criteria

October 25, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00045538
  • RES0021133 (Other Grant/Funding Number: University of Alberta Hospital Foundation)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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