Pharmacological Agents for Chronic Spinal Cord Injury (SCI)

Drug
Arm/hand function
Online since 24 October 2023, updated 175 days ago

About this trial

This trial is enrolling individuals with chronic, incomplete cervical spinal cord injuries to test the effect of three FDA-approved drugs (cyproheptadine (CPH), carbidopa-levodopa (CD-LD), and atomoxetine (ATX)), in combination with hand training exercises. If included, participants will receive hand training with either: 1) CPH; 2) CD-LD; 3) ATX; or 4) placebo. Participants will receive all four interventions in randomized order, at least a week apart. The study requires seven site visits, including an initial evaluation. Each visit will last 5 hours or less. Testing will measure arm and hand function. Also, surface recordings of muscle activity will be recorded during peripheral nerve stimulation and transcranial magnetic brain stimulation. Spinal cord function will be assessed during transcutaneous spinal cord stimulation.

Included participants

Gender
All
Age
18 - 65 years
Injury level
C1 - C8
  • Severity (AIS)?
  • Time since injury
    ≥ 12 months
    Healthy volunteers
    No
    C1-C8
    Additionally, participants must
    NOT have history of moderate to severe head trauma
    NOT have other neurological injury
    NOT have implanted stimulator, pacemaker, etc.

    What’s involved

    Type

    Drug

    Details

    - participants will receive hand training with either 1) CPH, 2) CD-LD, 3) ATX or 4) placebo. - seven visits in total, including an initial evaluation and clinical assessment session. Each visit will last roughly 5 hours or less. - Testing will include surface recordings of muscle activity during peripheral nerve stimulation and transcranial magnetic brain stimulation (TMS), and transcutaneous electrical spinal cord stimulation (TSCS).

    Potential benefits

    Main benefits

    Arm/hand function

    Additional benefits

    General health

    Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more

    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 20 Jan 2023
    • Organisation
    • Bronx VA Medical Center
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 20 Jan 2023
    • Organisation
    • Bronx VA Medical Center

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more