Nerve Transfer to Improve Function in High Level Tetraplegia

March 10, 2026 updated by: Wilson Z. Ray, Washington University School of Medicine

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

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.

Study Overview

Status

Recruiting

Conditions

Detailed 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)

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G-2E1
        • Not yet recruiting
        • University of Alberta
        • Principal Investigator:
          • Andrew Jack, MD
        • Contact:
  • United States
    • California
      • Stanford, California, United States, 94305
        • Recruiting
        • Stanford University
        • Contact:
        • Principal Investigator:
          • Thomas J Wilson, MD
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami
        • Contact:
        • Principal Investigator:
          • Stephen S Burks, MD
        • Contact:
        • Sub-Investigator:
          • Allan Levi, MD
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins University
        • Principal Investigator:
          • Sami Tuffaha, MD
        • Sub-Investigator:
          • Allan Belzberg, MD
        • Contact:
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Principal Investigator:
          • Yamaan Saadeh, MD
        • Contact:
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University in St. Louis
        • Principal Investigator:
          • Wilson Z. Ray, MD
        • Contact:
    • North Carolina
    • Pennsylvania
    • Texas
    • Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Elbow Dynamometry
Time Frame: 36-48 months post-surgery
Change from baseline to 36-48 months post-surgery. Elbow dynamometer measures muscle strength using a handheld portable dynamometer
36-48 months post-surgery
Electrodiagnosis (Nerve Conduction Study and Electromyography
Time Frame: 36-48 months post-surgery
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
Spinal Cord Independence Measure
Time Frame: 36-48 months post-surgery
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)
Time Frame: 36-48 months post-surgery
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Canadian Outcomes Performance Measure (COPM)
Time Frame: 36-48 Months post-surgery
Change from baseline to 36-48 months post-surgery. COPM is a validated outcome measure for SCI patients focusing on occupational performance in all areas of life. Scores range from 5-50 for performance and satisfaction. The higher scores reflect better performance and satisfaction.
36-48 Months post-surgery
Capabilities of Upper Extremity Questionnaire (CUE-Q)
Time Frame: 36-48 Months post-surgery
Change from baseline to 36-48 months post-surgery. CUE-Q detects changes in upper extremity function. Scores range from 32-224 with higher scores reflecting better function.
36-48 Months post-surgery
Modified Ashworth Scale (MAS)
Time Frame: 36-48 Months post-surgery
Change from baseline to 36-48 months post-surgery. MAS is a reliable measure for rating spasticity in SCI. Scores range from 0-32 with higher scores reflecting better function.
36-48 Months post-surgery
Spinal Cord Injury Quality of LIfe Questionnaire
Time Frame: 36-48 Months post-surgery
Change from baseline to 36-48 months post-surgery. SCI-QOL is designed to measure subjective quality of life in terms of satisfaction and importance. Range of scores is 0 to 30 with the higher scores reflecting a better quality of life..
36-48 Months post-surgery
International SCI Pain Basic Dataset (ISCIPBDS)
Time Frame: 36-48 Months post-surgery
Change from baseline to 36-48 months post-surgery. ISCIPBDS correctly classifies pain, determines its intensity and broad impact on daily activities. Lower scores reflect less pain/less interference in daily life.
36-48 Months post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

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

Investigators

  • Principal Investigator: Wilson Z. Ray, MD, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2024

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

February 23, 2024

First Submitted That Met QC Criteria

February 23, 2024

First Posted (Actual)

March 1, 2024

Study Record Updates

Last Update Posted (Actual)

March 11, 2026

Last Update Submitted That Met QC Criteria

March 10, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDMRP-eBRAP-SC220192

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Aggregate data will be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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