Transcutaneous Spinal Stimulation and Exercise for Locomotion

Technology
Standing/walking/mobility
Online since 3 November 2021, updated 839 days ago

About this trial

This clinical trial is enrolling individuals with incomplete spinal cord injuries to test the effect of transcutaneous (skin-surface) electrical stimulation of the spinal cord combined with physical therapy for improving locomotion (walking). The study will apply stimulation at both the cervical (neck) and the lumbosacral (low back) areas and will measure improvements in walking function. Participants will also undergo physical therapy (PT) to augment the effect of spinal stimulation on walking. Participants will be randomly placed in one of two study phases of 1 month each: PT only, and PT with spinal stimulation. The two phases will be repeated in reverse order of the original assignment (crossover). Sessions will last up to 2 hours/day, 2 to 5 days/week for each arm. Outcomes, both immediate and lasting, will be compared between the PT only versus PT plus spinal stimulation treatments.

Included participants

Gender
All
Age
21 - 70 years
Injury level
C1 - T12
  • Severity (AIS)?
  • AIS-C
    AIS-D
    Time since injury
    1 year - 70 years
  • Injury type
  • Traumatic

    Non-traumatic

    Healthy volunteers
    No
    C1-T12
    Additionally, participants must
    have the ability to attend up to 5 sessions per week physical therapy sessions and testing activities (Seattle, Washington) for up to 11 months.
    NOT dependent on ventilator support
    NOT have other implanted device, e.g. pacemaker

    What’s involved

    Type

    Technology

    Details

    2-4 study phases of 1 month each. Sessions will be done 2-5 days/week and will last up to 2 hours/day. Participation in stimulation, training, and assessment sessions for up to 11 months of study duration.

    Potential benefits

    Main benefits

    Standing/walking/mobility

    Additional benefits

    General health

    Mental 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
    • 28 Feb 2018
    • Organisation
    • University of Washington
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 28 Feb 2018
    • 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