Brain-controlled Spinal Cord Stimulation in Patients With Spinal Cord Injury

Technology
Standing/walking/mobility
Online since 5 November 2021, updated 959 days ago

About this trial

This is a clinical trial enrolling individuals with chronic spinal cord injuries to test combining an implanted device to record brain signal activity (intention to move) and spinal cord stimulation. Spinal cord stimulation is a technique for activating nerve networks to increase spinal cord function. Brain signals for intention to move are recorded on an implanted device (electrocorticogram) directly from the surface of the brain. The brain signals are decoded by computer and then sent to stimulation electrodes implanted on the spinal cord; this will enable voluntary muscle activity (such as leg movement), as intended. The goal is to provide direct communication between a person’s intention to move and the spinal cord. If included in the trial, participants will undergo a surgery to implant the device to measure brain activity, and another surgery to implant a stimulating device on the spinal cord. Additionally, a neurorehabilitation program will be performed. Testing will assess safety, function, and measures of gait performance over the period of 1 year.

Included participants

Gender
All
Age
18 - 65 years
Injury level
C1 - T10
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    AIS-D
    Time since injury
    12 months - 65 years
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C1-T10
    Additionally, participants must
    have completed the main phase of the STIMO (spinal cord stimulation) trial (NCT02936453)
    NOT have baclofen pump implanted
    NOT have other implanted device, e.g. pacemaker

    What’s involved

    Type

    Technology

    Details

    Participants are implanted with a (recording) device at the surface of the brain. Participants are implanted with a (stimulating) device at the surface of the spinal cord. The participants will undergo training and rehabilitation. Final testing will be performed at around 1 year. “Training specifications are not provided. Further information needs to be acquired directly from the investigator.”

    Potential benefits

    Main benefits

    Standing/walking/mobility

    Additional benefits

    Arm/hand function

    General health

    Mental health and psychosocial factors

    Sensory function

    Spasticity

    Mechanism of action

    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
    • Unknown
    • Trial start date
    • 4 Jul 2021
    • Organisation
    • Ecole Polytechnique Fédérale de Lausanne
    • Trial recruitment status
    • Unknown
    • Trial start date
    • 4 Jul 2021
    • Organisation
    • Ecole Polytechnique Fédérale de Lausanne

    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