Study on Preliminary Safety and Efficacy of the ARC Therapy Using the ARC-IM Lumbar System to Support Mobility in People With Chronic Spinal Cord Injury (BoxSwitch)

Technology
General health
Online since 21 November 2023, updated 140 days ago

About this trial

This trial is enrolling 8 individuals with chronic spinal cord injury to test the safety and effect of targeted epidural spinal stimulation on mobility. Targeted epidural spinal stimulation is a technique for stimulating the spinal cord with an implanted electrode array placed next to the spinal cord to modify spinal cord function. Only people with spinal cord injury who previously participated in the STIMO study (see NCT02936453) will be eligible to participate in this study. If included, participants will undergo surgery to replace parts of their current implanted system with components of the ARC-IM Lumbar system, followed by 20 optimization sessions. Then, participants will use the stimulation system independently during daily life activities for 36 months, at which point final testing of safety and mobility will be performed.

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
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C1-T10
    Additionally, participants must
    have completed the main phase of the STIMO study (NCT02936453) and improved on at least one of the primary or secondary endpoints

    What’s involved

    Type

    Technology

    Details

    - participants will undergo surgery to replace parts of their current implanted system with components of the ARC-IM Lumbar system - 20 optimization sessions that may include rehabilitation to configure the neuromodulation system - use of the ARC-IM system independently during daily life activities until the end of the 36 months post-surgery - final testing of safety and mobility will be performed after 36 months

    Potential benefits

    Main benefits

    General health

    Additional benefits

    Arm/hand function

    Mental health

    Sensory function

    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
    • Recruiting soon
    • Trial start date
    • 1 Aug 2023
    • Organisation
    • Ecole Polytechnique Fédérale de Lausanne
    • Trial recruitment status
    • Recruiting soon
    • Trial start date
    • 1 Aug 2023
    • 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