Noninvasive Spinal Stimulation to Restore Hand Function in Children With Spinal Cord Injury

Technology
Arm/hand function
Online since 26 October 2024, updated 39 days ago

About this trial

The main goal of this pilot study is to find the best ways to use transcutaneous spinal cord stimulation (scTS) to improve hand function in children with spinal cord injuries (SCI). The investigators ...

Included participants

Gender
All
Age
7 - 12 years
Injury level
C1 - C8
  • Severity (AIS)?
  • Time since injury
    ≥ 6 months
    Healthy volunteers
    No
    C1-C8

    What’s involved

    Type

    Technology

    Details

    After learning about the study and potential risks, parents/legal guardians and their eligible children with SCI will sign consent and assent forms, respectively. For the first two aims of the study, the investigators will recruit and enroll 10 participants. In the first week, participants will undergo clinical assessments from day 1 to day 4 to categorize the severity and level of their injuries and assess their current arm and hand function. On day 5, eligible participants will have experimental assessments to measure hand grip and control, both with and without spinal cord stimulation (scTS) at one or two neck sites optimized to improve hand grip. On day 6, participants will have similar assessments, this time adding stimulation to the trunk area to help with upright sitting and study its impact on hand grip and control. For the third aim, 4 participants who showed improved hand grip and control with stimulation in aims 1 and 2 will be selected on a first-come, first-served basis. They will undergo 20 sessions of activity-based upper extremity training, followed by 20 more sessions with the optimal stimulation sites identified from aims 1 and 2. After completing the training, participants will be asked to follow up and repeat experimental and clinical assessments to determine how long the improvements last.

    Potential benefits

    Main benefits

    Arm/hand function

    Additional benefits

    General health

    Pain

    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 Aug 2024
    • Organisation
    • University of Louisville
    • Trial recruitment status
    • Recruiting soon
    • Trial start date
    • 1 Aug 2024
    • Organisation
    • University of Louisville

    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