Comparison of Transcutaneous and Epidural Spinal Stimulation for Improving Function

Technology
Standing/walking/mobility
Online since 16 November 2021, updated 22 days ago

About this trial

This is a trial to compare two different types of spinal cord stimulation on overall motor (arm, trunk, and leg) function, bladder function, and quality of life in persons with chronic incomplete spinal cord injury. The two different types of spinal stimulation are: 1) spinal stimulation through non-invasive skin surface electrical stimulation (“transcutaneous spinal stimulation”; TransQ); and 2) spinal stimulation through surgically implanted electrodes next to the spinal cord (“epidural spinal stimulation”). The trial will consist of a phased intervention program and involve the following: 1) baseline (pre-intervention) testing; 2) physical therapy only; 3) TransQ stimulation plus physical therapy; 4) wash out/recovery (no intervention provided during this time); 5) epidural stimulation plus physical therapy; and 6) follow-up (a no-treatment period of time after the intervention is completed) testing. Additional functional testing will be performed at baseline and during the intervention and follow-up period.

Included participants

Gender
All
Age
21 - 70 years
Injury level
C1 - S5
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    AIS-D
    Time since injury
    1 year - 70 years
  • Injury type
  • Traumatic

    Non-traumatic

    Ischemia

    Healthy volunteers
    Yes
    C1-S5
    Additionally, participants must
    have difficulties walking, transferring, standing, and other activities of daily living.
    be willing and eligible to have a surgical implantation of the epidural stimulator for the indication of chronic pain.
    be able to attend 3-5 physical therapy sessions per week over 3 months.

    What’s involved

    Type

    Technology

    Details

    Participation in a phased intervention program that will involve the following: 1) baseline (pre-intervention) testing; 2) physical therapy only; 3) TransQ stimulation plus physical therapy; 4) wash out/recovery (no intervention provided during this time); 5) epidural stimulation plus physical therapy; and 6) follow-up (a no-treatment period of time after the intervention is completed) testing. Surgical implantation of an epidural stimulator for use in 5) above. Additional functional testing will be performed at baseline, during the intervention period, and at follow-up (at 8-11 months after beginning participation).

    Potential benefits

    Main benefits

    Standing/walking/mobility

    Additional benefits

    Bladder health

    General health

    Mental health

    Spasticity

    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

    • Recruitment
    • Unknown
    • Trial start date
    • 1 Aug 2019
    • Organisation
    • University of Washington
    • Recruitment
    • Unknown
    • Trial start date
    • 1 Aug 2019
    • Organisation
    • University of Washington

    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