RecruitingNCT06288763

Nerve Transfer to Improve Function in High Level Tetraplegia

Nerve Transfer to Restore Upper Limb Function and Quality of Life in High Tetraplegia


Sponsor

Washington University School of Medicine

Enrollment

30 participants

Start Date

Feb 5, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria7

  • 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 Criteria8

  • 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 the arm
  • Mentally or physically compromised making it impossible to complete study activities
  • Immunologically suppressed
  • Currently undergoing long-term steroid therapy
  • Active malignancy
  • Pregnancy

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Locations(10)

Stanford University

Stanford, California, United States

University of Miami

Miami, Florida, United States

Johns Hopkins University

Baltimore, Maryland, United States

University of Michigan

Ann Arbor, Michigan, United States

Washington University in St. Louis

St Louis, Missouri, United States

Wake Forest Medical Center

Winston-Salem, North Carolina, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Houston Methodist

Houston, Texas, United States

University of Utah

Salt Lake City, Utah, United States

University of Alberta

Edmonton, Alberta, Canada

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NCT06288763


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