Assessment of Neural Signals for the Control of Assistive Devices

Surgery
Arm/hand function
Online since 30 January 2025, updated 18 days ago

About this trial

This pilot study is enrolling 3 individuals with chronic cervical spinal cord injury to test the effect of a brain-computer interface (BCI) system on arm and hand function. BCI is a technique using a computer and connected electrodes on the scalp or implanted next to the brain to record brain activity and also to control an external device. Two participants will receive the intervention using scalp electrodes. The third participant receiving the intervention using the implanted electrodes is no longer being recruited. In this study, motor intention signals are decoded to control epidural spinal cord stimulation (SCS). SCS is a technique for stimulating the spinal cord with an implanted electrode placed next to the spinal cord to modify spinal cord function. If included, participants will undergo a one-time surgery to implant SCS leads temporarily, and will participate in therapist-guided upper limb task training for up to 2 months. Final testing of arm and hand function will be performed after 2 months.

Included participants

Gender
All
Age
≥ 18 years
Injury level
C4 - T1
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    AIS-D
    Time since injury
    ≥ 6 months
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C4-T1

    What’s involved

    Type

    Surgery

    Details

    - Two participants will undergo a one-time surgery to implant spinal cord stimulation (SCS) leads temporarily. They will then use a brain-computer interface (BCI) system to control the stimulation while engaging in therapist-guided upper limb task training for up to 2 months. - SCS is a technique for stimulating the spinal cord with an implanted electrode placed next to the spinal cord to modify spinal cord function. - BCI is a technique using a computer and connected electrodes on the scalp to record brain activity and also to control an external device. - Final testing of arm and hand function will be performed after 2 months.

    Potential benefits

    Main benefits

    Arm/hand function

    Additional benefits

    Bladder health/function

    Bowel health

    General health

    Mental health and psychosocial factors

    Pain

    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
    • Recruiting
    • Trial start date
    • 6 Sep 2024
    • Organisation
    • University of Miami
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 6 Sep 2024
    • Organisation
    • University of Miami

    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