Non-invasive Brain Stimulation Paired With FES Cycling Post SCI

Technology
Standing/walking/mobility
Online since 21 November 2023, updated 213 days ago

About this trial

This trial is enrolling 14 individuals with chronic incomplete spinal cord injuries at any level of the spinal cord to test the effect on lower extremity function of pairing repetitive Transcranial Magnetic Stimulation (rTMS) with Functional Electrical Stimulation (FES) Cycling. TMS is a non-invasive technique which uses a magnetic field to stimulate the brain using a coil (held over the head). FES is a technique that applies electrical stimulation through the skin to nerves to cause contraction of weakened or paralyzed muscles. The effect of the combined stimulation will be compared to each intervention alone. If included, participants will attend training sessions for 6 weeks, twice per week. Each will receive either the active rTMS or sham brain stimulation at the beginning of the session for 30 minutes, followed by electrical stimulation on their legs while cycling for 60 minutes. Final testing will be performed after 8 weeks.

Included participants

Gender
All
Age
≥ 18 years
Injury level
C1 - S5
  • Severity (AIS)?
  • AIS-C
    AIS-D
    Time since injury
    ≥ 1 year
    Healthy volunteers
    No
    C1-S5
    Additionally, participants must
    be able to walk independently for 10 meters without help from another person
    NOT have implanted electronic devices
    NOT have metal implants

    What’s involved

    Type

    Technology

    Details

    - Participants will receive either 1) active rTMS along with real FES cycling or 2) sham rTMS along with real FES cycling. - Repetitive Transcranial Magnetic Stimulation (rTMS) will be applied to the primary motor cortex of the brain. - Functional Electrical Stimulation (FES) will be applied to muscles associated in cycling: quadriceps, hamstrings, tibialis anterior, gastrocnemius, soleus. - Final testing of walking ability will be performed after 8 weeks.

    Potential benefits

    Main benefits

    Standing/walking/mobility

    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
    • 19 Sep 2023
    • Organisation
    • Western University, Canada
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 19 Sep 2023
    • Organisation
    • Western University, Canada

    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