Closed-loop Spinal Stimulation for Restoration of Upper Extremity Function After Spinal Cord Injury

Technology
Arm/hand function
Online since 13 December 2022, updated 482 days ago

About this trial

This is a trial enrolling individuals with chronic cervical spinal cord injuries to test the effect of transcutaneous electrical spinal cord stimulation (TSCS) on upper limb function. TSCS is a technique for stimulating the spinal cord via skin surface electrodes, in this case applied to the skin on the back of the neck. If included, participants will undergo repeated baseline measurements throughout four weeks, followed by intensive exercise therapy for six weeks. Then they will undergo either: 1) continuous TSCS(open-loop); or 2) activity-specific TSCS (closed-loop), followed by a 6-week waiting period without stimulation. Then they will receive the other intervention (closed or open-loop) for another 6 weeks. Each session will last 90 minutes, three sessions per week. Overall participation in the study will last ten months. The trial will include repeated measurements of arm and hand strength, sensation and function. Spasticity will also be assessed.

Included participants

Gender
All
Age
21 - 70 years
Injury level
C1 - C8
  • Severity (AIS)?
  • AIS-C
    AIS-D
    Time since injury
    ≥ 1 year
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C1-C8
    Additionally, participants must
    have difficulaties with hand functions in activities of daily living
    have the capability to perform simple cued motor tasks
    NOT be ventilator-dependent

    What’s involved

    Type

    Technology

    Details

    1) Repeated baseline measurements throughout four weeks, 2) Intensive exercise therapy for six weeks 3) Either i. continuous TSCS(open-loop) or ii. activity-specific TSCS (closed-loop) for 6 weeks 4) 6-week waiting period without stimulation 5) The other intervention (closed or open-loop) for another 6 weeks - Each session will last 90 minutes, three sessions per week. - Final testing will be performed at a 12 week follow up, for a total participation of 10 months

    Potential benefits

    Main benefits

    Arm/hand function

    Additional benefits

    Sensory function

    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

    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 12 Oct 2022
    • Organisation
    • University of Washington
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 12 Oct 2022
    • 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