Effects of 4-AP on Functional SCI Recovery

Drug
Standing/walking/mobility
Online since 22 September 2022, updated 573 days ago

About this trial

This trial is enrolling individuals spinal cord injuries for at least 4 weeks to test the effect a drug (Dalfampridine, 4-AP) in combination with spike timing dependent plasticity (STDP) stimulation and lower limb training on walking and other aspects of spinal cord function, including electrical measures of nerve conduction. STDP is a technique that applies paired electrical stimulation to the spinal cord and peripheral nerves. If included, participants will receive either: 1) 4-AP + STDP + training for 10 sessions; or 2) a placebo drug + STDP + training for 10 session. Following these sessions, participants in either arm of the study may be eligible for inclusion in an additional period of treatment with 4-AP + STDP + training for 40 sessions.

Included participants

Gender
All
Age
18 - 85 years
Injury level
C1 - L2
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    AIS-D
    Time since injury
    ≥ 4 weeks
    Healthy volunteers
    No
    C1-L2
    Additionally, participants must
    NO history of renal impairment
    NO debilitating disease prior to the SCI that caused exercise intolerance
    NO history of head injury or stroke

    What’s involved

    Type

    Drug

    Details

    Participants will receive either 1) the active drug (Dalfampridine) + STDP + training for 10 sessions, 2) the placebo drug + STDP + training for 10 session. They will then undergo a number of functional and electrical tests that will involve stimulation with electrodes on the skin. They may also be eligible for an additional period of treatment with the active drug + STDP + training for 40 sessions.

    Potential benefits

    Main benefits

    Standing/walking/mobility

    Additional benefits

    Bowel 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
    • 30 Jun 2022
    • Organisation
    • Shirley Ryan AbilityLab
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 30 Jun 2022
    • Organisation
    • Shirley Ryan AbilityLab

    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