Harnessing Neuroplasticity of Postural Sensorimotor Networks Using Non-Invasive Spinal Neuromodulation to Maximize Functional Recovery After Spinal Cord Injury

Technology
Standing/walking/mobility
Online since 21 June 2024, updated 26 days ago

About this trial

This trial is enrolling 60 individuals with chronic spinal cord injury between T2 and T10 to test the effect of spinal cord stimulation, both epidural (ESS) and transcutaneous (TSS), on lower limb function. Spinal cord stimulation is a technique using either implanted electrodes placed next to the spinal cord (ESS) or skin-surface electrodes (TSS) to stimulate the spinal cord and modify its function. If included, participants will undergo either: 1) surgery for implantation of the ESS device followed by ESS stimulation; 2) TSS stimulation; or 3) sham stimulation. Final testing of lower limb function, neurological status, and independence will be performed after 16 weeks.

Included participants

Gender
All
Age
22 - 60 years
Injury level
T2 - T10
  • Severity (AIS)?
  • AIS-A
    AIS-B
    Time since injury
    1 year - 6 years
    Healthy volunteers
    No
    T2-T10
    Additionally, participants must
    NOT have an intrathecal baclofen pump
    NOT have a history of neuromuscular condition

    What’s involved

    Type

    Technology

    Details

    - participants will undergo either 1) surgery for implantation of the ESS device followed by ESS stimulation, 2) TSS stimulation, or 3) sham stimulation. - Final testing of neurological function and independence will be performed after 16 weeks. - Participants that are in the ESS group have surgery to remove the stimulator towards the end of the study.

    Potential benefits

    Main benefits

    Standing/walking/mobility

    Additional benefits

    Arm/hand function

    General health

    Sensory function

    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
    • 6 Dec 2023
    • Organisation
    • The Methodist Hospital Research Institute
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 6 Dec 2023
    • Organisation
    • The Methodist Hospital Research Institute

    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