Nerve Transfer to Improve Function in High Level Tetraplegia

NCT06288763 | Recruiting

• 1 other identifier: CDMRP-eBRAP-SC220192
• Study Type: observational
• Target: 30
• Locations: 2 countries
• Sites: 10

Brief 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.

Conditions

Cervical Spinal Cord Injury; Tetraplegia

Keywords

Spinal Cord Injury; Cervical spinal cord injury; Nerve Transfer Surgery; High Cervical Spinal Cord Injury; Cervical SCI; Tetraplegia; Quadriplegia; Nerve transfer; Spinal Accessory Nerve

Outcome Measures

Primary Outcomes (4)

• Elbow Dynamometry

  Change from baseline to 36-48 months post-surgery. Elbow dynamometer measures muscle strength using a handheld portable dynamometer

  36-48 months post-surgery

• Spinal Cord Independence Measure

  Change from baseline to 36-48 months post-surgery. SCIM addresses three specific areas of function in patients with SCI, 1) Self-care (feeding, grooming, bathing, and dressing), 2) respiration and sphincter management, and 3) patient's mobility abilities (transfers from bed and indoors/outdoors). SCIM guide clinicians in determining treatment goals/objectives for SCI patients helping therapists assess measurable outcomes in their functional independence. Scores range from 0-100 with a higher score representing better function.

  36-48 months post-surgery

• Motor strength in medical research council grade (MRC)

  Change in baseline to 36-48 Months post-surgery. The manual muscle testing is a reliable measure of motor strength when assessed by a trained examiner. Scores range from 0-5, with the highest number representing a better score.

  36-48 months post-surgery

• Electrodiagnosis (Nerve Conduction Study and Electromyography

  Change in baseline to 36-48 Months post-surgery. NCS/EMG evaluate neuromuscular health and inform the integrity of lower motor neurons.

  36-48 months post-surgery

Secondary Outcomes (5)

• Canadian Outcomes Performance Measure (COPM)

  36-48 Months post-surgery

• Capabilities of Upper Extremity Questionnaire (CUE-Q)

  36-48 Months post-surgery

• Modified Ashworth Scale (MAS)

  36-48 Months post-surgery

• Spinal Cord Injury Quality of LIfe Questionnaire

  36-48 Months post-surgery

• International SCI Pain Basic Dataset (ISCIPBDS)

  36-48 Months post-surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with high-level SCI injury (C1-C4) with complete lack of upper extremity function. Occurrence of injury should be greater than 6 months but fewer than 60 months

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: collaborator
• The Methodist Hospital Research Institute: collaborator
• University of Pennsylvania: collaborator
• University of Utah: collaborator
• Washington University School of Medicine: lead
• Stanford University: collaborator
• University of Miami: collaborator
• Johns Hopkins University: collaborator
• University of Alberta: collaborator
• Wake Forest University Health Sciences: collaborator
• Department of Defense / Congressionally Mandated Research Program (CDMRP): collaborator

Study Sites (10)

Stanford University

Stanford, California, 94305, United States

RECRUITING

University of Miami

Miami, Florida, 33136, United States

RECRUITING

Johns Hopkins University

Baltimore, Maryland, 21287, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Washington University in St. Louis

St Louis, Missouri, 63110, United States

RECRUITING

Wake Forest Medical Center

Winston-Salem, North Carolina, 27157, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Houston Methodist

Houston, Texas, 77030, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84132, United States

RECRUITING

University of Alberta

Edmonton, Alberta, T6G-2E1, Canada

NOT YET RECRUITING

Related Links

• Washington University Neurosurgery Website

MeSH Terms

Conditions

Quadriplegia; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Wilson Z. Ray, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Linda Koester, BS

CONTACT

314-362-7368; koesterl@wustl.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD - Principal Investigator

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: March 1, 2024
• Study Start: February 5, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (9)