Acute Effects of Pharmacological Neuromodulation on Leg Motor Activity in Patients With SCI Treated With EES

Technology
General health
Online since 8 November 2021, updated 840 days ago

About this trial

This is a trial to test the safety, tolerability of single-dose drugs, either busipirone, levodopa/carbidopa, a combination of both, or placebo, in individuals with spinal cord injury. The second objective is to assess the effects of these drugs on spasticity, lower limb strength and voluntary movements and walking using a bodyweight support system device (i.e. robot). If included, the participant will receive 1) buspirone, 2) levodopa/carbidopa, 3) busipirone + levodopa/carbidopa, and 4) placebo , in random order. The clinicians and participants will not be able to tell the difference between the drugs. After each drug treatment, participants will be assessed for safety and also for lower extremity spasticity, muscle strength, voluntary movement, and robot assisted walking ability.

Included participants

Gender
All
Age
18 - 65 years
Injury level
C1 - T10
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    AIS-D
    Time since injury
    ≥ 1 month
  • Injury type
  • Traumatic

    Healthy volunteers
    Yes
    C1-T10
    Additionally, participants must
    Only participants who have completed the main phase of the STIMO study will be invited to participate in this trial.
    In addition, the participant must:
    have a spinal cord injury for at least 12 months.

    What’s involved

    Type

    Technology

    Details

    If included, the participant will receive 1) buspirone, 2) levodopa/carbidopa, 3) busipirone + levodopa/carbidopa, and 4) placebo , in random order. After each drug treatment, participants will be assessed for safety and also for lower extremity spasticity, muscle strength, voluntary movement, and robot assisted walking ability.

    Potential benefits

    Main benefits

    General health

    Additional benefits

    Spasticity

    Standing/walking/mobility

    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
    • Ended
    • Trial start date
    • 11 Sep 2020
    • Organisation
    • Centre Hospitalier Universitaire Vaudois
    • Trial recruitment status
    • Ended
    • Trial start date
    • 11 Sep 2020
    • Organisation
    • Centre Hospitalier Universitaire Vaudois

    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