Transcutaneous Spinal Stimulation: Safety and Feasibility for Upper Limb Function in Children With Spinal Cord Injury

Technology
General health
Online since 4 November 2021, updated 895 days ago

About this trial

This trial is recruiting children with cervical (neck area) spinal cord injuries to test the safety, comfort, and practicality of spinal cord stimulation (SCS) to activate arms and hands. SCS is a technique that may activate spinal cord nerve networks. This study will use non-invasive skin-surface electrodes. In adults with chronic SCI, this form of stimulation has been shown to assist with trunk control immediately after treatment, and to improve arm and hand function when combined with specific types of exercise training. If selected for the trial, participants will receive intermittent cervical SCS sessions for no more than 10 minutes at a time. Participants will receive SCS while upper extremity function is assessed at three time points, and/or SCS will be given in combination with activity-based upper extremity training (40 sessions, 1.5 hours/day, 5 days/week). Outcomes for grasping, pinching, and reaching movements will be measured. The long-term goal is to provide better therapies so children with SCI can successfully play and accomplish everyday tasks using their arms and hands.

Included participants

Gender
All
Age
4 - 18 years
Injury level
C1 - T1
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    AIS-D
    Time since injury
    1 year - 18 years
  • Injury type
  • Traumatic

    Non-traumatic

    Healthy volunteers
    No
    C1-T1
    Additionally, participants must
    be discharged from in-patient rehabilitation
    have moderate to severe upper extremity functional deficit
    NOT have congenital spinal cord injury

    What’s involved

    Type

    Technology

    Details

    Cervical spinal cord stimulation with surface electrodes (non-invasive) For some participants, SCS with activity-based upper extremity training (40 sessions, 1.5 hours/day, 5 days/week) will be performed Participation in periodic follow-up measurements for 3 months

    Potential benefits

    Main benefits

    General health

    Additional benefits

    Arm/hand function

    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
    • Trial start date
    • 14 Nov 2019
    • Organisation
    • University of Louisville
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 14 Nov 2019
    • 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