Spinal Stimulation in Chronic Spinal Cord Injury

Technology
Arm/hand function
Online since 4 November 2021, updated 895 days ago

About this trial

This is a clinical trial investigating the effects of spinal cord stimulation combined with physical therapy on sensory, motor and autonomic functions in individuals with chronic spinal cord injuries. Spinal cord stimulation (SCS) is a technique that uses an electric current to change the activity of the nerves in the spinal cord. This study uses skin-surface electrodes placed above the spinal cord. Physical therapy targeting the arms and legs is included (activity-based rehabilitation). If included in the study, participants will undergo spinal cord stimulation with electrodes applied to the skin, as well as arm and leg physical therapy. There are three treatment arms, including 1) those with complete cervical (neck area) injuries; 2) those with complete motor paraplegia (chest level); and 3) those with incomplete injuries. Researchers want to see if stimulation plus physical therapy can cause lasting improvements in sensory, motor, respiratory or autonomic function, which might lead to a greater functional independence and quality of life for participants.

Included participants

Gender
All
Age
≥ 18 years
Injury level
C4 - T12
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    AIS-D
    Time since injury
    ≥ 1 year
  • Injury type
  • Traumatic

    Vertebrae fracture

    Healthy volunteers
    No
    C4-T12
    Additionally, participants must
    NOT be dependent on ventilator
    NOT implanted with device or hardware that interferes with MRI

    What’s involved

    Type

    Technology

    Details

    Transcutaneous spinal cord stimulation applied with electrodes applied to the skin. Training duration was nt specified Activity-based rehabilitation (physical therapy) Follow-up measurements for up to 1 year on muscle, skin, & autonomic function, breathing ability, spasticity, independence in daily activities, standing balance (where applicable), and quality of life.

    Potential benefits

    Main benefits

    Arm/hand function

    Additional benefits

    Bladder health/function

    Bowel health

    General health

    Spasticity

    Standing/walking/mobility

    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
    • Ended
    • Trial start date
    • 11 Nov 2019
    • Organisation
    • The Neurokinex Charitable Trust
    • Trial recruitment status
    • Ended
    • Trial start date
    • 11 Nov 2019
    • Organisation
    • The Neurokinex Charitable Trust

    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