Nerve Transfer to Improve Function in High Level Tetraplegia

Last updated: November 11, 2024
Sponsor: Washington University School of Medicine
Overall Status: Active - Recruiting

Phase

N/A

Condition

Spinal Cord Injuries

Limb Spasticity

Treatment

N/A

Clinical Study ID

NCT06288763
SC220192
  • Ages 18-80
  • All Genders

Study Summary

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.

Participants will:

  • undergo standard of care pre- and post-op testing and study exams

  • complete pre- and post-questionnaires

  • undergo standard of care nerve transfer surgeries

  • follow-up with surgeon at 6/12/18/24/36 and potentially at 48 months

  • attend therapy at local therapist for up to 2 years postop.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18-80 years of age

  • High cervical SCI (motor level C1-C4)

  • Motor complete SCI AIS grade A-B

  • Plateaued spontaneous recovery for at least 6 months of non-operative therapy

  • SCI greater than 6 months and fewer than 60 months since injury

  • At least MRC 4/5 donor strength

  • Mentally and physically willing and able to comply with evaluations

Exclusion

Exclusion Criteria:

  • Active infection at the operative site or systemic infection

  • Any return or ongoing recovery of distal motor function

  • Significant joint contractures and/or limitations in passive range of motion in thearm

  • Mentally or physically compromised making it impossible to complete study activities

  • Immunologically suppressed

  • Currently undergoing long-term steroid therapy

  • Active malignancy

  • Pregnancy

Study Design

Total Participants: 30
Study Start date:
February 05, 2024
Estimated Completion Date:
December 31, 2028

Study Description

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)

Connect with a study center

  • University of Calgary - Alberta Health Services

    Calgary, Alberta T2N 2T9
    Canada

    Site Not Available

  • University of Alberta

    Edmonton, Alberta T6G 2E1
    Canada

    Site Not Available

  • Stanford University

    Stanford, California 94305
    United States

    Active - Recruiting

  • University of Miami

    Miami, Florida 33136
    United States

    Active - Recruiting

  • Johns Hopkins University

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • Washington University in St. Louis

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Houston Methodist

    Houston, Texas 77030
    United States

    Active - Recruiting

  • University of Utah

    Salt Lake City, Utah 84132
    United States

    Active - Recruiting

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