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BCI-Assisted SCS-EXS for Gait Optimization

Technology
General health
Online since 4 September 2025, updated 98 days ago
Curated trial

About this trial

This feasibility trial is enrolling 3 participants with chronic spinal cord injury to test the safety of a brain-computer interface (BCI)-assisted epidural spinal stimulation (eSS) system with exoskeleton-based rehabilitation. A BCI is a technique using a computer and connected electrodes on the brain to record brain activity and to decode motor intent to control an external device. eSS is an invasive technique that uses an implanted electrode placed next to the spinal cord to deliver electrical stimulation aimed at modifying spinal cord function. If included, participants will undergo implantation of BCI and eSS electrodes, followed by 1-hour long rehabilitation sessions using an exoskeleton, 5 times per week for 1 year. Final testing of safety and feasibility will be performed after 1 year.

Included participants

Gender
All
Age
14 - 65 years
Injury level
C1 - S5
  • Severity (AIS)?
    • AIS-A
    AIS-B
    AIS-C
    Time since injury
    ≥ 6 months
  • Injury type

    • Traumatic

    Non-traumatic

    Ischemia

    Spinal cord stroke

    Stenosis

    Spondylosis

    Cancer

    Healthy volunteers
    No
    C1-S5
    Additionally, participants must
    NOT have other active implantable devices except for SCS or BCI devices (e.g., pacemakers, defibrillators, drug infusion pumps, cochlear implants, sacral nerve stimulators)

    What’s involved

    Type

    Technology

    Details

    - Participants will undergo implantation of brain-computer interface (BCI) components and epidural spinal stimulation (eSS) electrodes, followed by 1-hour long rehabilitation sessions using an exoskeleton, 5 times per week for 1 year. - A BCI is a technique using a computer and connected electrodes on the brain to record brain activity and also to control an external device. - eSS is an invasive technique that uses an implanted electrode placed next to the spinal cord to deliver electrical stimulation aimed at modifying spinal cord function. - Final testing of safety and feasibility will be performed after 1 year.

    Potential benefits

    Main benefits

    General health

    Additional benefits

    Bladder health/function

    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
    • 23 Apr 2025
    • Organisation
    • Xuanwu Hospital, Beijing
    View on clinicaltrials.gov
    for more details
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 23 Apr 2025
    • Organisation
    • Xuanwu Hospital, Beijing
    View on clinicaltrials.gov
    for more details

    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

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