Nerve Transfer to Improve Function in High Level Tetraplegia
NCT ID: NCT06288763
Last Updated: 2025-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
30 participants
OBSERVATIONAL
2024-02-05
2028-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Nerve Transfer After Spinal Cord Injury- Multi-center
NCT04023591
Upper Extremity Surgery in Spinal Cord Injury
NCT01899664
Nerve Transfer Surgery to Restore Upper-limb Function After Cervical Spinal Cord Injury
NCT05638191
Restoring Hand Function Utilizing Nerve Transfers in Persons With Cervical Spinal Cord Injuries
NCT03451474
Combined Nerve and Tendon Transfer for the Restoration of Hand Function in Individuals With Tetraplegia
NCT04276181
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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)
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Wilson Z. Ray
OTHER
University of Michigan
OTHER
The Methodist Hospital Research Institute
OTHER
University of Pennsylvania
OTHER
University of Utah
OTHER
Stanford University
OTHER
University of Miami
OTHER
Johns Hopkins University
OTHER
University of Alberta
OTHER
Wake Forest University Health Sciences
OTHER
Department of Defense / Congressionally Mandated Research Program (CDMRP)
UNKNOWN
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Wilson Z. Ray
MD - Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Wilson Z. Ray, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Role: backup
Related Links
Access external resources that provide additional context or updates about the study.
Washington University Neurosurgery Website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CDMRP-eBRAP-SC220192
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.