TetraplegiaNCT04023591
Nerve Transfer After Spinal Cord Injury- Multi-center
An observational study of Tetraplegia and Spinal Cord Injuries, run by Washington University School of Medicine at 9 sites in 2 countries.
Trial summary
Current treatment strategies of acute cervical spinal cord injuries remain limited. Treatment options that provide meaningful improvements in patient quality of like and long-term functional independence will provide a significant public health impact. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tetraplegia, Spinal Cord Injuries, Quadriplegia Flaccid
- What is being tested?
- Surgery/Occupational Therapy
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 13 Apr 2020to Dec 2030
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with a traumatic cervical spine injury with little to no use of his/her arms/hands.
Who may be able to join
- Age 18-65, inclusive
- At least 3 months of non-operative rehab therapy
- Mentally and physically willing and able to comply with evaluations
- Less than 36 months post-injury
- Stable ASIA scores with no evidence of functional improvement in motor or sensory examination for at least 3 months
- ASIA A or B determined by the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
Show all 9Show fewer
- EMG/NCS verifies intact innervation (normal CMAPs) to the paralyzed target muscles below the level of injury
- Functional electrical stimulation (FES) will be performed. Subject must have clinically normal MRC grade 5/5 donor (axonal) function
- Injury Level C4-C8
Who cannot join
- Active infection at the operative site or systemic infection
- Any return or ongoing clinical recovery of distal motor function
- Mentally or physically compromised that will prevent them from complying with evaluations.
- Immunologically suppressed
- Currently undergoing long-term steroid therapy
- Active malignancy
Show all 10Show fewer
- Pregnant
- Significant joint contractures and/or limitations in passive range of motion in the arm or hand, per treating surgeon's discretion
- Lack of appropriate social support and/or infrastructure to commit to scheduled follow-up visits.
- Patients who are planning on undergoing a tendon transfer during the study period or who have had a tendon transfer in the past.
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States7 sites
University of Michigan
Ann Arbor, Michigan, 48109
Houston Methodist
Houston, Texas, 77030
University of Miami
Miami, Florida, 33136
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Utah
Salt Lake City, Utah, 84132
Washington University
St Louis, Missouri, 63110
Stanford University
Stanford, California, 94305
Canada2 sites
Alberta Health Services - Foothills Medical Center
Calgary, Alberta, T2N 2T9
University of Alberta
Edmonton, Alberta, T6G 2E1
About this study
Official title: Nerve Transfers to Improve Upper Extremity Function and Quality of Life in Tetraplegic Patients
Current treatment strategies of acute cervical spinal cord injuries remain limited. Treatment options that provide meaningful improvements in patient quality of like and long-term functional independence will provide a significant public health impact. Specific aim: Measure the efficacy of nerve transfer surgery in the treatment of patients with complete spinal cord injuries with no hand function. Optimize the efficiency of nerve transfer surgery by evaluating patient outcomes in relation to patient selection and quality of life and functional independence.
Read the detailed description
Study Design and Feasibility: A prospective multi-institutional non-randomized single arm design will be utilized. Seventy subjects with cervical ASIA A-B (International Standards for Neurological Classification of Spinal Cord Injury) SCI and hand function impairment that fit the International Classification for Surgery of the Hand 0-4 will be identified. Only patients with stable ASIA scores and no evidence of functional improvement in motor or sensory examination for at least 3 months will be recruited. All patients will undergo Electromyography (EMG) and nerve conduction studies (NCS) to verify intact innervation (normal compound muscle action potentials (CMAPs)) to the paralyzed target muscles below the level of injury. Functional electrical stimulation (FES) will be used to verify loss of lower motor neuron function in key muscle groups in the zone of injury and help differentiate those muscle with intact connections to preserve anterior horn cells. Only those patients with clinically normal, Medical Research Council (MRC) muscle grade 5/5 donor (axonal donor) function will be enrolled.
Outcome Measures Primary Outcome Measures: Pre- and Post-operative upper motor strength. (Manual motor testing \& Hand Held Dynamometry) Secondary Outcome Measures: Disabilities of the Arm, Shoulder, and Hand (DASH), Michigan Hand Questionnaire (MHQ), Spinal Cord Injury Quality of Life (SCIQOL), GRASSP test (pre-operative, post-operatively - 6 months, 12 months, and 24 months, 36 months and 48 months), rates of intraoperative and post-operative complications, and rates of reoperation.
Rehabilitation and hand therapy are critical components of motor re-education following nerve transfers. Cortical plasticity and motor remapping occurs following nerve transfers allowing independent functional control of the recipient muscles. All patients will begin rehabilitation and hand therapy beginning 2 weeks after surgery. They undergo one hour of hand therapy and occupational therapy for motor re-education once to twice a week for 48 months following surgery. Rehabilitation will be phased to early and late - added exercises focusing on co-contraction, repetition, and range of motion will be included as home therapy.
- Conditions
- Tetraplegia, Spinal Cord Injuries, Quadriplegia Flaccid
- Being tested
- Surgery/Occupational Therapy
- Keywords
- tetraplegia, spinal cord injury, quadriplegia, nerve transfer
- Medical subject headings
- Quadriplegia, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery/Occupational TherapyProcedure or surgery
Surgery based on function and injury/ Occupational therapy for 48 months post-surgery
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Surgery/ Occupational Therapy Receives: Procedure: Surgery/Occupational Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Manual Motor Testing
Change from baseline testing strength of upper extremities at 48 months post-operatively
Measured: 48 months
Handheld Dynamometry
Change from baseline grip strength at 48 months post-operatively
Measured: 48 months
Secondary outcomes (7)
Change in Disabilities of Arm, Shoulder and Hand (DASH) scores
Change from baseline DASH scores at 48 months post-operatively. Scores range from 0-100 with 0 being the most positive score representing no arm, shoulder or hand disability and 100 being the lowest score indicating the most severe arm, shoulder and hand disability.
Measured: 48 months
Change in Spinal Cord Injury Quality of Life (SCIQOL) scores
Change in baseline SCIQOL scores at 48 months post-operatively. Five scores of 0-30 (0=less satisfied and 30=most satisfied) are calculated: 1. Total Quality of Life; 2. Health and Functioning Subscale; 3. Social and Economic Subscale; 4. Psychological/Spiritual Subscale; 5 Family Subscale. Calculation of scores weighs satisfaction scores according to level of importance assigned to each item. An overall score can be obtained by summing the scores for all six scales after reversing the pain scale and dividing by six.
Measured: 48 months
Rates of Intra-operative and post-operative complications
The number of complications within and after the operation
Measured: 48 months
Hand Function, measured by the GRASSP test
Change in baseline GRASSP Test results for hand function at 48 months post-operatively
Measured: 48 months
Changes in the Graded Redefined Assessment of Strength, Sensation and Prehension scores (GRASSP)
Change in baseline GRASSP results for strength, sensation and prehension at 48 months post-operatively. Five subtests: 1. Dorsal sensation (3 locations) each scored 0-4 (sum =subtest score, 0-12, with 0 being no sensation and 12 being normal sensation); 2. Palmar sensation (same as above); 3. Strength (10 muscles of arms and hand), motor grad 0-5 for each (sum = subtest total 0-50 with 0 being worst score and 50 being full motor function in all muscles); 4. Prehension ability - 3 grasps (cylindrical, lateral key, tip to tip) - each scored 0-4 (sum=subtest score, 0-12 with 0 being worst function and 12 being no dysfunction); 5 Prehension performance - 6 prehension tasks (pour water, open jars, pick up and turn key, transfer 9 pegs from board, pick up four coins and place in slot and screw 4 nuts on bolt - each scored 0-5 (sum=subtest score 0-30 with 0 being worst score to 30 being best possible score.
Measured: 48 months
Neuro Quality of Life - Depression Short Form (NQOL-Dep)
Changes in baseline NQOL-Dep scores at 48 months post-operatively. Scores range from 8-40 with 8 being best outcome and 40 being the worst outcome
Measured: 48 months
Neuro Quality of Life - Upper Extremity Short Form (NQOL-UEF)
Changes in baseline NQOL-UEF scores at 48 months post-operatively. Scores range from 8-40 with 40 being the best outcome and 8 being the worst possible outcome.
Measured: 48 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start13 Apr 2020
- Primary completionMar 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TetraplegiaStudies 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University, University of Pennsylvania, University of Michigan, University of Calgary, University of Utah, United States Department of Defense, The Methodist Hospital Research Institute, University of Miami, University of Alberta
- Responsible party
- Sponsor
- Investigators
- Wilson Z Ray, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04023591
- Sponsor's protocol ID
- SC180063
- Status last verified
- Jun 2026
- First submitted
- 11 Jul 2019
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share individual participant data. Only aggregate data will be published.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nerve Transfers to Improve Upper Extremity Function and Quality of Life in Tetraplegic Patients
- ClinicalTrials.gov ID
- NCT04023591
- Acronym / sponsor ID
- SC180063
- Conditions
- Tetraplegia, Spinal Cord Injuries, Quadriplegia Flaccid
- Keywords
- tetraplegia, spinal cord injury, quadriplegia, nerve transfer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Stanford University, University of Pennsylvania, University of Michigan, University of Calgary, University of Utah, United States Department of Defense, The Methodist Hospital Research Institute, University of Miami, University of Alberta
- Study start
- 13 Apr 2020 (actual)
- Primary completion
- Mar 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 17 Jul 2019 (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.
Current treatment strategies of acute cervical spinal cord injuries remain limited. Treatment options that provide meaningful improvements in patient quality of like and long-term functional independence will provide a significant public health impact. Specific aim: Measure the efficacy of nerve transfer surgery in the treatment of patients with complete spinal cord injuries with no hand function. Optimize the efficiency of nerve transfer surgery by evaluating patient outcomes in relation to patient selection and quality of life and functional independence.
Detailed description
Study Design and Feasibility: A prospective multi-institutional non-randomized single arm design will be utilized. Seventy subjects with cervical ASIA A-B (International Standards for Neurological Classification of Spinal Cord Injury) SCI and hand function impairment that fit the International Classification for Surgery of the Hand 0-4 will be identified. Only patients with stable ASIA scores and no evidence of functional improvement in motor or sensory examination for at least 3 months will be recruited. All patients will undergo Electromyography (EMG) and nerve conduction studies (NCS) to verify intact innervation (normal compound muscle action potentials (CMAPs)) to the paralyzed target muscles below the level of injury. Functional electrical stimulation (FES) will be used to verify loss of lower motor neuron function in key muscle groups in the zone of injury and help differentiate those muscle with intact connections to preserve anterior horn cells. Only those patients with clinically normal, Medical Research Council (MRC) muscle grade 5/5 donor (axonal donor) function will be enrolled.
Outcome Measures Primary Outcome Measures: Pre- and Post-operative upper motor strength. (Manual motor testing \& Hand Held Dynamometry) Secondary Outcome Measures: Disabilities of the Arm, Shoulder, and Hand (DASH), Michigan Hand Questionnaire (MHQ), Spinal Cord Injury Quality of Life (SCIQOL), GRASSP test (pre-operative, post-operatively - 6 months, 12 months, and 24 months, 36 months and 48 months), rates of intraoperative and post-operative complications, and rates of reoperation.
Rehabilitation and hand therapy are critical components of motor re-education following nerve transfers. Cortical plasticity and motor remapping occurs following nerve transfers allowing independent functional control of the recipient muscles. All patients will begin rehabilitation and hand therapy beginning 2 weeks after surgery. They undergo one hour of hand therapy and occupational therapy for motor re-education once to twice a week for 48 months following surgery. Rehabilitation will be phased to early and late - added exercises focusing on co-contraction, repetition, and range of motion will be included as home therapy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgery | – | Procedure: Surgery/Occupational TherapySurgery/ Occupational Therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with a traumatic cervical spine injury with little to no use of his/her arms/hands.
Key inclusion criteria (9 listed)
- Age 18-65, inclusive
- At least 3 months of non-operative rehab therapy
- Mentally and physically willing and able to comply with evaluations
- Less than 36 months post-injury
- Stable ASIA scores with no evidence of functional improvement in motor or sensory examination for at least 3 months
Key exclusion criteria (10 listed)
- Active infection at the operative site or systemic infection
- Any return or ongoing clinical recovery of distal motor function
- Mentally or physically compromised that will prevent them from complying with evaluations.
- Immunologically suppressed
- Currently undergoing long-term steroid therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgery/Occupational TherapySurgery based on function and injury/ Occupational therapy for 48 months post-surgery | Procedure or surgery | Surgery |
Primary outcome
Manual Motor Testing
Time frame: 48 months
Change from baseline testing strength of upper extremities at 48 months post-operatively
Handheld Dynamometry
Time frame: 48 months
Change from baseline grip strength at 48 months post-operatively
7 secondary outcomes
Change in Disabilities of Arm, Shoulder and Hand (DASH) scores
Time frame: 48 months
Change in Spinal Cord Injury Quality of Life (SCIQOL) scores
Time frame: 48 months
Rates of Intra-operative and post-operative complications
Time frame: 48 months
Hand Function, measured by the GRASSP test
Time frame: 48 months
Changes in the Graded Redefined Assessment of Strength, Sensation and Prehension scores (GRASSP)
Time frame: 48 months
Neuro Quality of Life - Depression Short Form (NQOL-Dep)
Time frame: 48 months
Neuro Quality of Life - Upper Extremity Short Form (NQOL-UEF)
Time frame: 48 Months
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 17 Jun 2026.
- Washington University Neurosurgery WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. No plan to share individual participant data. Only aggregate data will be published.
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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. This study is not recruiting at the moment.
Wilson Z Ray, MD principal investigator
Washington University School of Medicine
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tetraplegia and Spinal Cord Injuries, run by Washington University School of Medicine at 9 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 9 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Manual Motor Testing (time frame: 48 months). The study lists 2 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 17 Jun 2026; AzTrials last refreshed its copy on 2 Nov 2026.