A Novel Combined Neuromodulation Therapy to Enhance Balance and Neuroplasticity

Technology
Standing/walking/mobility
Online since 12 December 2023, updated 69 days ago

About this trial

This trial is enrolling 20 individuals with chronic incomplete spinal cord injuries to test the effect of combining functional electrical stimulation (FES) and transcutaneous spinal cord stimulation (TSCS) during visual feedback training (VFT). The goal is to improve standing balance. FES is a technique that applies electrical stimulation through the skin to nerves to cause contraction of weakened or paralyzed muscles. TSCS is a technique that applies electrical stimulation through the skin to target the spinal cord and associated neural pathways, thus affecting neural activity. VFT uses computer game simulations so participants can actively follow visual feedback of body sway. If included, participants will receive 12 sessions of either TSCS + FES, or FES alone during balance training using visual feedback on a computer screen, over 4 weeks. Final testing will be performed after 6 weeks.

Included participants

Gender
All
Age
18 - 80 years
Injury level
C1 - T12
  • Severity (AIS)?
  • AIS-C
    AIS-D
    Time since injury
    ≥ 1 year
  • Injury type
  • Traumatic

    Non-traumatic

    Healthy volunteers
    No
    C1-T12
    Additionally, participants must
    NOT have history of epilepsy
    NOT have implanted electronic devices
    NOT have peripheral nerve damage in the legs

    What’s involved

    Type

    Technology

    Details

    - Participants will be assigned to receive either the combined intervention of transcutaneous spinal cord stimulation (TSCS) and functional electrical stimulation (FES), or FES alone during balance training for 12 training sessions over 4 weeks. - Balance training will include visual feedback training (VFT) games for both groups. - FES is a technique that applies electrical stimulation through the skin to nerves to cause contraction of weakened or paralyzed muscles. - TSCS is a technique that applies electrical stimulation through the skin to target the spinal cord and associated neural pathways, aiming to influencing neural activity. - Final testing will be performed after 6 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 soon
    • Trial start date
    • 1 Sep 2023
    • Organisation
    • University Health Network, Toronto
    • Trial recruitment status
    • Recruiting soon
    • Trial start date
    • 1 Sep 2023
    • Organisation
    • University Health Network, Toronto

    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