Cervical Spinal Cord InjuryNCT06288763
Nerve Transfer to Improve Function in High Level Tetraplegia
An observational study of Cervical Spinal Cord Injury and Tetraplegia, run by Washington University School of Medicine at 10 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cervical Spinal Cord Injury, Tetraplegia
- How many people
- 30 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 5 Feb 2024to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 2 countries
United States9 sites, 9 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Savannah Solomon, 734-936-7010, ssavanna@med.umich.edu
Yamaan Saadeh, MD
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21287
Chava Roberts, 667-306-8862, crober83@jh.edu
Ala Elhelali, aelhela1@jhmi.edu
- Recruiting
Houston Methodist
Houston, Texas, 77030
Amber Behne, 346-238-6424, abehne@houstonmethodist.org
Sergio Ibarra Cortez, 346-238-2494, shibarracortez@houstonmethodist.org
- Recruiting
University of Miami
Miami, Florida, 33136
George Jimsheleishvili, MD, 305-243-4781, gxi150@med.miami.edu
Patricia Graham, 305-243-5119, pgraham1@med.miami.edu
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Leah Coghlan, 215-341-5864, leah.coghlan@pennmedicine.upenn.edu
Gabrielle Dupre, gabrielle.dupre@pennmedicine.upenn.edu
- Recruiting
University of Utah
Salt Lake City, Utah, 84132
Kirstianna Lombardi, 801-585-9821, kirstianna.lombardi@utah.edu
Douglas Gibula, douglas.gibula@hsc.utah.edu
- Recruiting
Washington University in St. Louis
St Louis, Missouri, 63110
Linda Koester, 13143627368, koesterl@wustl.edu
Wilson Z. Ray, MD
- Recruiting
Stanford University
Stanford, California, 94305
Anthony Bet, 650-683-5823, abet0915@stanford.edu
Thomas J Wilson, MD
- Recruiting
Wake Forest Medical Center
Winston-Salem, North Carolina, 27157
Wendy Jenkins, 336-716-3842, wendy.jenkins@advocatehealth.org
Kim Hawley, kimberly.hawley@advocatehealth.org
Canada1 site, 1 recruiting
- Not yet recruiting
University of Alberta
Edmonton, Alberta, T6G-2E1
Mithun Rajshekar, PhD, 780-248-1896, rajsheka@ulaberta.ca
Andrew Jack, MD
About this study
Official title: 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.
Read the 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)
- 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
- Medical subject headings
- Quadriplegia, Spinal Cord Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Elbow Dynamometry
Change from baseline to 36-48 months post-surgery. Elbow dynamometer measures muscle strength using a handheld portable dynamometer
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 36-48 months post-surgery
Secondary outcomes (5)
Canadian Outcomes Performance Measure (COPM)
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.
Measured: 36-48 Months post-surgery
Capabilities of Upper Extremity Questionnaire (CUE-Q)
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.
Measured: 36-48 Months post-surgery
Modified Ashworth Scale (MAS)
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.
Measured: 36-48 Months post-surgery
Spinal Cord Injury Quality of LIfe Questionnaire
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..
Measured: 36-48 Months post-surgery
International SCI Pain Basic Dataset (ISCIPBDS)
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.
Measured: 36-48 Months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start5 Feb 2024
- Primary completion1 Mar 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan, The Methodist Hospital Research Institute, University of Pennsylvania, University of Utah, Stanford University, University of Miami, Johns Hopkins University, University of Alberta, Wake Forest University Health Sciences, Congressionally Directed Medical Research Programs
- Responsible party
- Principal investigator, Wilson Z. Ray, Washington University School of Medicine
- Investigators
- Wilson Z. Ray, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06288763
- Sponsor's protocol ID
- CDMRP-eBRAP-SC220192
- Status last verified
- Mar 2026
- First submitted
- 23 Feb 2024
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Aggregate data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nerve Transfer to Restore Upper Limb Function and Quality of Life in High Tetraplegia
- ClinicalTrials.gov ID
- NCT06288763
- Acronym / sponsor ID
- CDMRP-eBRAP-SC220192
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- University of Michigan, The Methodist Hospital Research Institute, University of Pennsylvania, University of Utah, Stanford University, University of Miami, Johns Hopkins University, University of Alberta, Wake Forest University Health Sciences, Congressionally Directed Medical Research Programs
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 1 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
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.
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.
5 secondary outcomes
Canadian Outcomes Performance Measure (COPM)
Time frame: 36-48 Months post-surgery
Capabilities of Upper Extremity Questionnaire (CUE-Q)
Time frame: 36-48 Months post-surgery
Modified Ashworth Scale (MAS)
Time frame: 36-48 Months post-surgery
Spinal Cord Injury Quality of LIfe Questionnaire
Time frame: 36-48 Months post-surgery
International SCI Pain Basic Dataset (ISCIPBDS)
Time frame: 36-48 Months post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Washington University Neurosurgery WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. Aggregate data will be shared
Related trials for Cervical Spinal Cord Injury
Enrolling by invitation
NeuroSuitUp: Neurorehabilitation Through Synergistic Man-machine Interfaces
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Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01)
Brainstem Stroke, ALS
Recruiting
Augmenting Upper Limb Function and Functional Neuroplasticity Using Epidural Stimulation of the Cervical Spinal Cord
Spinal Cord Injuries, Cervical Spinal Cord Injury
Active, not recruitingObservational study
Nerve Transfer Surgery to Restore Upper-limb Function After Cervical Spinal Cord Injury
Spinal Cord Injury, Spinal Cord Injury at C5-C7 Level
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NG004 in Incomplete Spinal Cord Injury Patients
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wilson Z. Ray, MD principal investigator
Washington University School of Medicine
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Spinal Cord Injury and Tetraplegia, run by Washington University School of Medicine at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Linda Koester, BS (314-362-7368, koesterl@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Elbow Dynamometry (time frame: 36-48 months post-surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.