Spinal Cord InjuryNCT01714349
Nerve Transfer After Spinal Cord Injuries
A study testing Nerve Transfer in people with Spinal Cord Injury, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Nerve Transfer surgery can provide improved hand function following cervical spinal cord injuries Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Nerve Transfer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to 20 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- 18-65 years of age
- Informed Consent Document (ICD) signed by patient
- Cervical spinal cord injury resulting in arm \& hand functional impairment, with at least preserved elbow function
- International Classification of Surgery of the Hand in Tetraplegia (ICSHT) category 0 - 4
- Patients with a stable American Spinal Injury Association (ASIA) grade of A, B, or C, or with a diagnosis of central cord syndrome, showing minimal to no evidence of functional improvement in motor examination after at least 6 months of non-operative therapy post-injury
- Appropriate candidate for nerve transfer study
- Willing and able to comply with the study protocol
- < 48 months from injury
Who cannot join
- Active infection at the operative site or systemic infection
- Any return or ongoing clinical recovery of distal motor function within 6 months after injury
- Physically or mentally compromised
- Currently undergoing long-term steroid therapy
- Significant joint contractures and/or limitations in passive range of motion in the arm or hand
- Active malignancy
Show all 13Show fewer
- Systemic disease that would affect the patient's welfare or the research study
- Pregnant
- Immunologically suppressed or immunocompromised
- Significant pain or hypersensitivity
- Previous or current injury preventing use of tendon transfers to restore upper extremity function
- Affective disorder of a degree that would make outcome assessment and study participation difficult
- History of brachial plexus injury or systemic neuropathic process
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Restoring Hand Function Using Nerve Transfers in Persons With Spinal Cord Injury
Nerve Transfer surgery can provide improved hand function following cervical spinal cord injuries
Read the detailed description
Current treatment strategies of acute cervical spinal cord injuries remain limited. Treatment options that provide meaningful improvements in patient quality of life 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 cervical spinal cord injuries with no hand function. Optimize the efficiency of nerve transfer surgery by evaluating patient outcomes in relation to patient selection and optimal timing the the surgery.
Hypothesis: Peripheral nerve transfers in patients with spinal cord injuries will improve hand function and provide improvement in patient quality of life and functional independence.
- Conditions
- Spinal Cord Injury
- Being tested
- Nerve Transfer
- Keywords
- Spinal cord injury, nerve transfer, tetraplegia, quadriplegia
- Medical subject headings
- Spinal Cord Injuries, Quadriplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve TransferProcedure or surgery
A nerve transfer procedure will be individualized to each patient's functional deficit.
| Study group | Role | What they receive |
|---|---|---|
| Nerve Transfer | Experimental | Surgical - Nerve transfers for patients with stable cervical spinal cord injuries Receives: Procedure: Nerve Transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in upper motor strength
Patients motor strength will be assessed over 48 months of clinical follow-up with conventional manual motor testing
Measured: 48 months
Secondary outcomes (3)
Change in Disabilities of Arm, Shoulder, and Hand (DASH) scores
The change in DASH scores will be followed over time and assessed pre-operatively, 6,12, 18, 24, 36 and 48 months post-operatively.
Measured: 48 months
Change in Short Form 36 (SF-36) scores
The change in SF-36 scores will be followed over time and assessed pre-operatively, 6, 12, 18, 24. 36 and 48 months post-operatively.
Measured: 48 months
Change in Michigan Hand Questionnaire (MHQ)
The change in MHQ will be followed over time and assessed pre-operatively, 6, 12, 18, 24, 36 and 48 months post-operatively.
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 posted25 Oct 2012 (estimated)
- Study startOct 2012
- Primary completion20 Mar 2023
- Study completion20 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, Congressionally Directed Medical Research Programs
- Responsible party
- Sponsor
- Investigators
- Wilson Z Ray, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01714349
- Sponsor's protocol ID
- NTSCI -201208137
- Other IDs
- CDMRP-SC140051
- Status last verified
- Jul 2026
- First submitted
- 22 Oct 2012
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoring Hand Function Using Nerve Transfers in Persons With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT01714349
- Acronym / sponsor ID
- NTSCI -201208137
- Conditions
- Spinal Cord Injury
- Keywords
- Spinal cord injury, nerve transfer, tetraplegia, quadriplegia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- United States Department of Defense, Congressionally Directed Medical Research Programs
- Study start
- Oct 2012
- Primary completion
- 20 Mar 2023 (actual)
- Study completion
- 20 Mar 2023 (actual)
- First posted
- 25 Oct 2012 (estimated)
- 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.
Nerve Transfer surgery can provide improved hand function following cervical spinal cord injuries
Detailed description
Current treatment strategies of acute cervical spinal cord injuries remain limited. Treatment options that provide meaningful improvements in patient quality of life 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 cervical spinal cord injuries with no hand function. Optimize the efficiency of nerve transfer surgery by evaluating patient outcomes in relation to patient selection and optimal timing the the surgery.
Hypothesis: Peripheral nerve transfers in patients with spinal cord injuries will improve hand function and provide improvement in patient quality of life and functional independence.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nerve Transfer | Experimental | Procedure: Nerve TransferSurgical - Nerve transfers for patients with stable cervical spinal cord injuries |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18-65 years of age
- Informed Consent Document (ICD) signed by patient
- Cervical spinal cord injury resulting in arm \& hand functional impairment, with at least preserved elbow function
- International Classification of Surgery of the Hand in Tetraplegia (ICSHT) category 0 - 4
- Patients with a stable American Spinal Injury Association (ASIA) grade of A, B, or C, or with a diagnosis of central cord syndrome, showing minimal to no evidence of functional improvement in motor examination after at least 6 months of non-operative therapy post-injury
Key exclusion criteria (13 listed)
- Active infection at the operative site or systemic infection
- Any return or ongoing clinical recovery of distal motor function within 6 months after injury
- Physically or mentally compromised
- Currently undergoing long-term steroid therapy
- Significant joint contractures and/or limitations in passive range of motion in the arm or hand
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 |
|---|---|---|
| Nerve TransferA nerve transfer procedure will be individualized to each patient's functional deficit. | Procedure or surgery | Nerve Transfer |
Primary outcome
Change in upper motor strength
Time frame: 48 months
Patients motor strength will be assessed over 48 months of clinical follow-up with conventional manual motor testing
3 secondary outcomes
Change in Disabilities of Arm, Shoulder, and Hand (DASH) scores
Time frame: 48 months
Change in Short Form 36 (SF-36) scores
Time frame: 48 months
Change in Michigan Hand Questionnaire (MHQ)
Time frame: 48 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Washington University Neurosurgery Home PageLink provided by the sponsor.
Related trials for Spinal Cord Injury
Recruiting
Implant for Walking After Incomplete SCI
Spinal Cord Injury (SCI), Gait
Recruiting
MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System
Paralysis; Quadriplegic, Quadraplegia
Recruiting
tSCS Combined With Rehabilitation Training in Treating Paraplegic Patients After SCI
Spinal Cord Injury, Paraplegia, Spinal
Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
Recruiting
Neuromodulation for Metabolic Dysfunction
Spinal Cord Injuries (SCI), Prediabetes / Type 2 Diabetes
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nerve Transfer in people with Spinal Cord Injury, run by Washington University School of Medicine at 1 site in United States.
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 8 inclusion and 13 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: finished, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in upper motor strength (time frame: 48 months). 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 6 Jul 2026.