Nerve Transfer to Improve Function in High Level Tetraplegia

Arm/hand function
Online since 3 April 2024, updated 6 days ago

About this trial

The goal of this observational study is to determine if nerve transfer surgeries improve upper extremity function and quality of life in patients with a high level cervical spinal cord injury. Partic...

Included participants

Gender
All
Age
18 - 80 years
Injury level
C1 - C4
  • Severity (AIS)?
  • AIS-A
    AIS-B
    Time since injury
    6 months - 60 months
    Healthy volunteers
    No
    C1-C4
    Additionally, participants must
    undergo nerve transfer surgery

    What’s involved

    Type

    Observational

    Details

    Restoration of function in patients with high tetraplegia has been an elusive clinical challenge. There is a critical need to find an effective reconstructive therapy/procedure which improves the upper extremity function in patients with high tetraplegia. One pure motor nerve - spinal accessory nerve (SAN) remains a viable donor in high tetraplegia patients to successfully restore elbow flexion or extension. Elbow function can provide profound independence in mobility, ventilator management and may broaden the application of assistive therapies. The two objectives of this study are: Determine if SAN nerve transfer surgery can improve the reinnervation of bicep or tricep muscles in high tetraplegia patients. Determine if SAN nerve transfer surgery can reanimate upper arm function and improve functional independence in patients with high tetraplegia. Study Activities (including standard of care (SOC)) Electrodiagnosis pre-op (SOC) Upper extremity maximum muscle testing (SOC) Questionnaires (SOC and study-related (SR)) Exams by a study therapist (SR) Neurological exam - ISNCSCI - (SOC) Nerve Transfer Surgery to be determined by surgeon (SOC) Follow-up visits with surgeon at 6/12/18/24/36 and potentially 48 months post-op electrodiagnostic testing (SR) post-op upper extremity maximum muscle testing (SOC) post-op questionnaires post-op therapy exams (SR)

    Potential benefits

    Main benefits

    Arm/hand function

    Additional benefits

    Bladder health

    Bowel health

    General health

    Mental health

    Pain

    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
    • Trial start date
    • 5 Feb 2024
    • Organisation
    • Washington University School of Medicine
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 5 Feb 2024
    • Organisation
    • Washington University School of Medicine

    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