QuadriplegiaNCT01899664
Upper Extremity Surgery in Spinal Cord Injury
A study testing Nerve Transfer Surgery in people with Quadriplegia and Spinal Cord Diseases, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The goal of the investigators work is to establish how nerve transfers can be best used to improve upper extremity function in patients with cervical level spinal cord injury (SCI). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Quadriplegia, Spinal Cord Diseases, Spinal Cord Injuries
- What is being tested?
- Nerve Transfer Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Oct 2021
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- clinical diagnosis of cervical level spinal cord injury
- some upper extremity dysfunction (ex: lack of wrist extension or hand function)
- greater then 6 months post-injury or with stable neurologic function for at least 6 months post-injury
- good access to and ability to pay for hand and physical therapy
- ability to comply and participate in rigorous post-surgical therapy regimen
Who cannot join
- severe autonomic dysreflexia
- open pressure sores or other wounds
- respiratory insufficiency
- untreated urinary tract infections
- lack of access to physical therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University Division of Plastic Surgery
St Louis, Missouri, 63110
About this study
Official title: Study of the Surgical Treatment of Cervical Spinal Cord Injuries With Nerve Transfers to Restore Upper Extremity and Hand Function
The goal of the investigators work is to establish how nerve transfers can be best used to improve upper extremity function in patients with cervical level spinal cord injury (SCI). The investigators' hypothesis is that nerve transfers are safe and effective and will improve function and quality of life in patients with loss of upper function due to spinal cord injury. The investigators plan on looking at upper limb function, and health-related quality of life in patients before and after surgery to better understand how patients benefit from these treatments.
A nerve transfer procedure can be used to rewire the system to make some muscles work again following SCI. The nerve transfer procedure (which is done in the arm and not at the level of the spinal cord) can be used to bypass the damaged area and to deliver a signal from the brain to a muscle that became disconnected following that injury. A donor nerve is taken from another muscle whose use is not essential and then transferred to help in providing more a more critical function.
Read more
For example, one type of nerve transfer is done to restore the lost ability to pinch or grasp small objects between the fingers that occurs in many patients with cervical SCI. In this surgery, a donor nerve that normally helps flex the elbow. This nerve can be used because the biceps muscle is also working to flex the elbow. This donor nerve is cut and re-attached to the nerve going to muscles in the forearm that provide pinch by bending the tips of the thumb and index finger.
Because the nerve transfer procedure involves cutting and reattaching nerve and muscle tissues, time is required to regenerate working connections between the nerves and muscle as well as to allow the brain to relearn how to use and strengthen that muscle.
Read the detailed description
Background/Readiness
Cervical spinal cord injury (SCI) is a life altering injury that results in profound loss of upper limb function. Nerve transfer surgery has transformed the field of peripheral nerve injury surgery, allowing remarkable restoration of upper limb motor function. The investigators expanded use of nerve transfer surgery to cervical SCI patients and are the first center to successfully restore volitional hand function in a patient with a C7 motor level injury (now 3 years post-surgery). Results in 7 more patients show early functional gains at 3-6 months post-surgery (most gains are expected at 12 months and these patients are still early in their course). The proposed study will obtain formative outcomes data from a pilot investigation of nerve transfer surgery to restore upper extremity function in patients with cervical SCI.
Upper extremity and hand function is essential to basic activities of daily living and independence; patients with cervical SCI rate this as more important than walking and sexual performance. Restoration of critical upper extremity and hand function requires the unique expertise and technical skill of hand surgeons; traditionally tendon transfer/tenodesis are used. Although studies report reasonable outcomes in SCI patients for this procedure, use is limited particularly in the US.
Nerve transfers offer an alternative and promising approach. In peripheral nerve injury, nerve transfers are well-established, safe and are often the treatment of choice. A nerve transfer uses an expendable donor nerve and coapts this to a nonfunctional recipient nerve to restore volitional motor function. Since a nerve transfer reinnervates the musculotendinous unit responsible for the absent but desired function, this procedure: 1) does not have the biomechanical limitations of tendon transfers; 2) can use expendable donor nerves whose muscles cannot be used for tendon transfer (i.e. the brachialis); and 3) a single donor nerve can provide more than one function via reinnervation of multiple muscles. Most importantly for SCI patient acceptability, nerve transfers do not require prolonged periods of immobilization; early resumption of activity is encouraged.
Preliminary Data:
Case reports offer early evidence that this novel application of nerve transfers may be a better alternative to tendon transfers in SCI. Based on our extensive experience with nerve transfers in peripheral nerve injury, we expect this approach will have a profound impact on improving function, independence and health-related quality of life (QoL).
The purpose of this study is to provide evidence on the feasibility, safety, and outcomes of nerve transfers in SCI patients via systematically collected data and to evaluate patients' perspective of the benefits and disadvantages of nerve transfers. These data are vital for patient selection, patient and surgeon education, and adaptation of this well-established technique to this unique and traditionally underserved patient population.
Hypothesis and Approach:
Hypothesis: Nerve transfers are safe, effective procedures that have a role in the treatment armamentarium of cervical SCI associated upper extremity dysfunction.
Aim 1: To document the safety, time course and improvement (potential for nerve transfers to improve functional outcomes) by assessing pre and post-operative function.
Aim 2: To evaluate the feasibility and suitability of nerve transfers through multidisciplinary evaluation, electrodiagnostic testing, ultrasound, and nerve specimen examination and correlation with the clinical outcome.
Aim 3: To assess patient satisfaction with and acceptability for this treatment by use of semi-structured patient interviews.
- Conditions
- Quadriplegia, Spinal Cord Diseases, Spinal Cord Injuries
- Being tested
- Nerve Transfer Surgery
- Keywords
- peripheral nerves, quadriplegia, nerve transfer, surgical procedures, operative, hand, upper extremity, quality of life
- Medical subject headings
- Quadriplegia, Spinal Cord Diseases, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve Transfer SurgeryProcedure or surgery
Unilateral surgery will be performed under general non-paralytic anesthesia and no-tourniquet conditions to allow for responsive nerve simulation.
| Study group | Role | What they receive |
|---|---|---|
| Primary Study Population | Other | Study participants (primary study population) will include patients with spinal cord injury at the mid cervical level who are undergoing evaluation for possible surgical treatment with nerve transfers and or tendon transfer/tenodesis to improve their upper extremity function. All enrolled participants will receive the same standard of care surgical procedures. Receives: Procedure: Nerve Transfer Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper extremity function.
Upper extremity function as measured by manual muscle testing and range of motion as well as the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) test (this is a standardized functional test to assess upper extremity function in patients with spinal cord injury) and International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) test (this is an examination used to determine the motor and sensory impairment and severity of a spinal cord injury).
Measured: change from baseline at 6, 12, 24, 30 and 36 months post-surgery
Secondary outcomes (1)
Health related quality of life.
The Short Form (SF) -36, Spinal Cord Independence Measure (SCIM), Canadian Occupational Performance Measure (COPM) will be used to provide information about the patients quality of life and function.
Semi-structured interviews will be performed at 12-18 months following surgery to gain information about patient satisfaction, acceptability, and the subjective experience of the surgical intervention, therapy and functional outcome.
Measured: change from baseline at 6, 12, 24, 30 and 36 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 posted15 Jul 2013 (estimated)
- Study startJun 2012
- Primary completionOct 2021
- Study completionOct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for QuadriplegiaStudies 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
- Model description
- Subjects will undergo the following: A full International Standards for Neurological Classification of SCI exam will be completed to determine exact function and type of spinal cord injury. A phone interview will be completed at both preoperative and postoperative time points. Quality of life before and after surgical intervention will be derived from standardized questionnaires: Spinal Cord Independence Measure (SCIM), SF-36, Novak scale, and pain questionnaires. Additional qualitative and quantitative data on donor and recipient nerve function and tissue will be derived from preoperative electrodiagnostic studies. Specimens of the donor and recipient nerve are collected for histologic analysis during the operative procedure. Those trimmed nerve specimens are then analyzed for clinical purposes to give patients an idea of expected outcome in a more timely fashion.
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ida K. Fox, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01899664
- Sponsor's protocol ID
- 201205104
- Status last verified
- Nov 2021
- First submitted
- 3 Jul 2013
- Last updated
- 3 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Fox IK, Davidge KM, Novak CB, Hoben G, Kahn LC, Juknis N, Ruvinskaya R, Mackinnon SE. Nerve Transfers to Restore Upper Extremity Function in Cervical Spinal Cord Injury: Update and Preliminary Outcomes. Plast Reconstr Surg. 2015 Oct;136(4):780-792. doi: 10.1097/PRS.0000000000001641.
PubMed 26397252Fox IK, Davidge KM, Novak CB, Hoben G, Kahn LC, Juknis N, Ruvinskaya R, Mackinnon SE. Use of peripheral nerve transfers in tetraplegia: evaluation of feasibility and morbidity. Hand (N Y). 2015 Mar;10(1):60-7. doi: 10.1007/s11552-014-9677-z.
PubMed 25767422Hill EJR, Fox IK. Current Best Peripheral Nerve Transfers for Spinal Cord Injury. Plast Reconstr Surg. 2019 Jan;143(1):184e-198e. doi: 10.1097/PRS.0000000000005173.
PubMed 30589809
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Surgical Treatment of Cervical Spinal Cord Injuries With Nerve Transfers to Restore Upper Extremity and Hand Function
- ClinicalTrials.gov ID
- NCT01899664
- Acronym / sponsor ID
- 201205104
- Conditions
- Quadriplegia, Spinal Cord Diseases, Spinal Cord Injuries
- Keywords
- peripheral nerves, quadriplegia, nerve transfer, surgical procedures, operative, hand, upper extremity, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Oct 2021 (actual)
- Study completion
- Oct 2021 (actual)
- First posted
- 15 Jul 2013 (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.
The goal of the investigators work is to establish how nerve transfers can be best used to improve upper extremity function in patients with cervical level spinal cord injury (SCI). The investigators' hypothesis is that nerve transfers are safe and effective and will improve function and quality of life in patients with loss of upper function due to spinal cord injury. The investigators plan on looking at upper limb function, and health-related quality of life in patients before and after surgery to better understand how patients benefit from these treatments.
A nerve transfer procedure can be used to rewire the system to make some muscles work again following SCI. The nerve transfer procedure (which is done in the arm and not at the level of the spinal cord) can be used to bypass the damaged area and to deliver a signal from the brain to a muscle that became disconnected following that injury. A donor nerve is taken from another muscle whose use is not essential and then transferred to help in providing more a more critical function.
For example, one type of nerve transfer is done to restore the lost ability to pinch or grasp small objects between the fingers that occurs in many patients with cervical SCI. In this surgery, a donor nerve that normally helps flex the elbow. This nerve can be used because the biceps muscle is also working to flex the elbow. This donor nerve is cut and re-attached to the nerve going to muscles in the forearm that provide pinch by bending the tips of the thumb and index finger.
Because the nerve transfer procedure involves cutting and reattaching nerve and muscle tissues, time is required to regenerate working connections between the nerves and muscle as well as to allow the brain to relearn how to use and strengthen that muscle.
Detailed description
Background/Readiness
Cervical spinal cord injury (SCI) is a life altering injury that results in profound loss of upper limb function. Nerve transfer surgery has transformed the field of peripheral nerve injury surgery, allowing remarkable restoration of upper limb motor function. The investigators expanded use of nerve transfer surgery to cervical SCI patients and are the first center to successfully restore volitional hand function in a patient with a C7 motor level injury (now 3 years post-surgery). Results in 7 more patients show early functional gains at 3-6 months post-surgery (most gains are expected at 12 months and these patients are still early in their course). The proposed study will obtain formative outcomes data from a pilot investigation of nerve transfer surgery to restore upper extremity function in patients with cervical SCI.
Upper extremity and hand function is essential to basic activities of daily living and independence; patients with cervical SCI rate this as more important than walking and sexual performance. Restoration of critical upper extremity and hand function requires the unique expertise and technical skill of hand surgeons; traditionally tendon transfer/tenodesis are used. Although studies report reasonable outcomes in SCI patients for this procedure, use is limited particularly in the US.
Nerve transfers offer an alternative and promising approach. In peripheral nerve injury, nerve transfers are well-established, safe and are often the treatment of choice. A nerve transfer uses an expendable donor nerve and coapts this to a nonfunctional recipient nerve to restore volitional motor function. Since a nerve transfer reinnervates the musculotendinous unit responsible for the absent but desired function, this procedure: 1) does not have the biomechanical limitations of tendon transfers; 2) can use expendable donor nerves whose muscles cannot be used for tendon transfer (i.e. the brachialis); and 3) a single donor nerve can provide more than one function via reinnervation of multiple muscles. Most importantly for SCI patient acceptability, nerve transfers do not require prolonged periods of immobilization; early resumption of activity is encouraged.
Preliminary Data:
Case reports offer early evidence that this novel application of nerve transfers may be a better alternative to tendon transfers in SCI. Based on our extensive experience with nerve transfers in peripheral nerve injury, we expect this approach will have a profound impact on improving function, independence and health-related quality of life (QoL).
The purpose of this study is to provide evidence on the feasibility, safety, and outcomes of nerve transfers in SCI patients via systematically collected data and to evaluate patients' perspective of the benefits and disadvantages of nerve transfers. These data are vital for patient selection, patient and surgeon education, and adaptation of this well-established technique to this unique and traditionally underserved patient population.
Hypothesis and Approach:
Hypothesis: Nerve transfers are safe, effective procedures that have a role in the treatment armamentarium of cervical SCI associated upper extremity dysfunction.
Aim 1: To document the safety, time course and improvement (potential for nerve transfers to improve functional outcomes) by assessing pre and post-operative function.
Aim 2: To evaluate the feasibility and suitability of nerve transfers through multidisciplinary evaluation, electrodiagnostic testing, ultrasound, and nerve specimen examination and correlation with the clinical outcome.
Aim 3: To assess patient satisfaction with and acceptability for this treatment by use of semi-structured patient interviews.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects will undergo the following: A full International Standards for Neurological Classification of SCI exam will be completed to determine exact function and type of spinal cord injury. A phone interview will be completed at both preoperative and postoperative time points. Quality of life before and after surgical intervention will be derived from standardized questionnaires: Spinal Cord Independence Measure (SCIM), SF-36, Novak scale, and pain questionnaires. Additional qualitative and quantitative data on donor and recipient nerve function and tissue will be derived from preoperative electrodiagnostic studies. Specimens of the donor and recipient nerve are collected for histologic analysis during the operative procedure. Those trimmed nerve specimens are then analyzed for clinical purposes to give patients an idea of expected outcome in a more timely fashion.
| Arm | Type | Receives |
|---|---|---|
| Primary Study Population | Other | Procedure: Nerve Transfer SurgeryStudy participants (primary study population) will include patients with spinal cord injury at the mid cervical level who are undergoing evaluation for possible surgical treatment with nerve transfers and or tendon transfer/tenodesis to improve their upper extremity function. All enrolled participants will receive the same standard of care surgical procedures. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- clinical diagnosis of cervical level spinal cord injury
- some upper extremity dysfunction (ex: lack of wrist extension or hand function)
- greater then 6 months post-injury or with stable neurologic function for at least 6 months post-injury
- good access to and ability to pay for hand and physical therapy
- ability to comply and participate in rigorous post-surgical therapy regimen
Key exclusion criteria (5 listed)
- severe autonomic dysreflexia
- open pressure sores or other wounds
- respiratory insufficiency
- untreated urinary tract infections
- lack of access to physical 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 |
|---|---|---|
| Nerve Transfer SurgeryUnilateral surgery will be performed under general non-paralytic anesthesia and no-tourniquet conditions to allow for responsive nerve simulation. | Procedure or surgery | Primary Study Population |
Primary outcome
Upper extremity function.
Time frame: change from baseline at 6, 12, 24, 30 and 36 months post-surgery
Upper extremity function as measured by manual muscle testing and range of motion as well as the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) test (this is a standardized functional test to assess upper extremity function in patients with spinal cord injury) and International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) test (this is an examination used to determine the motor and sensory impairment and severity of a spinal cord injury).
1 secondary outcome
Health related quality of life.
Time frame: change from baseline at 6, 12, 24, 30 and 36 months post-surgery
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 3 Nov 2021.
- Results publication: PubMed 26397252Fox IK, Davidge KM, Novak CB, Hoben G, Kahn LC, Juknis N, Ruvinskaya R, Mackinnon SE. Nerve Transfers to Restore Upper Extremity Function in Cervical Spinal Cord Injury: Update and Preliminary Outcomes. Plast Reconstr Surg. 2015 Oct;136(4):780-792. doi: 10.1097/PRS.0000000000001641.
- Results publication: PubMed 25767422Fox IK, Davidge KM, Novak CB, Hoben G, Kahn LC, Juknis N, Ruvinskaya R, Mackinnon SE. Use of peripheral nerve transfers in tetraplegia: evaluation of feasibility and morbidity. Hand (N Y). 2015 Mar;10(1):60-7. doi: 10.1007/s11552-014-9677-z.
- Derived from this study: PubMed 30589809Hill EJR, Fox IK. Current Best Peripheral Nerve Transfers for Spinal Cord Injury. Plast Reconstr Surg. 2019 Jan;143(1):184e-198e. doi: 10.1097/PRS.0000000000005173.
- Patient information and intake forms.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Ida K. Fox, 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 Surgery in people with Quadriplegia and Spinal Cord Diseases, 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 5 inclusion and 5 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 3 Nov 2021. 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?
Upper extremity function. (time frame: change from baseline at 6, 12, 24, 30 and 36 months post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01899664, which also lists 3 linked publications.
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 3 Nov 2021.