Brain-Controlled Spinal Stimulation Walking Therapy After Incomplete Spinal Cord Injury (SCI)

Technology
Standing/walking/mobility
Online since 7 October 2024, updated 74 days ago

About this trial

This trial is enrolling 10 participants with chronic incomplete spinal cord injury to test the effect of Brain-Computer Interface (BCI)-Transcutaneous Spinal Cord Stimulation (TSCS) on walking function. BCI is a technique using a computer and non-invasive connected electrodes on the scalp to record brain activity and also to control an external device. TSCS is a technique for stimulating the spinal cord via surface stimulation to modify spinal cord function. If included, participants will undergo BCI-TSCS therapy 3-4 times per week, which includes activity-based training for up to 6 months. The TSCS is activated by a BCI system that detects movement attempts. Final testing of walking function will be performed after 6 months.

Included participants

Gender
All
Age
21 - 70 years
Injury level
C1 - T10
  • Severity (AIS)?
  • AIS-B
    AIS-C
    AIS-D
    Time since injury
    ≥ 6 months
    Healthy volunteers
    No
    C1-T10
    Additionally, participants must
    NOT have traumatic brain injury, stroke, multiple sclerosis, or other neuromuscular disorders that could affect neuromotor function and walking.
    NOT have metal implants in their head
    walk overground for at least 10 meters with some assistance of a therapist and minimal body-weight support

    What’s involved

    Type

    Technology

    Details

    - Participants will undergo Brain-Computer Interface (BCI)-Transcutaneous Spinal Cord Stimulation (TSCS) therapy 3-4 times per week, which includes activity-based training. - BCI is a technique using a computer and connected electrodes on the scalp to record brain activity and also to control an external device. - TSCS is a technique for stimulating the spinal cord via surface stimulation to modify spinal cord function. - During the therapy sessions, the TSCS is activated by a BCI system that detects movement attempts. - Final testing of walking function will be performed after 6 months.

    Potential benefits

    Main benefits

    Standing/walking/mobility

    Additional benefits

    Arm/hand function

    General health

    Mental health and psychosocial factors

    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
    • 7 May 2024
    • Organisation
    • University of Miami
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 7 May 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