QuadriplegiaNCT02861612
Nerve Transfers to Restore Hand Function in Spinal Cord Injury
An observational study of Quadriplegia and Spinal Cord Diseases, run by Ottawa Hospital Research Institute at 2 sites in 2 countries.
Trial summary
This study seeks to evaluate the efficacy of nerve transfers in restoring hand function in patients with cervical spinal injuries. 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
- How many people
- 0 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Aug 2016to 18 Mar 2019
- Phase
- Observational
- 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
Study population: Any patients with cervical spinal cord injury and upper extremity dysfunction who are medically stable, residents of Canada, willing and able to be assessed at the The Ottawa Hospital are potential participants.
Who may be able to join
- Patients with a spinal cord injury AIS level C5 to C7. Those with motor complete injuries (AIS A or B) will be considered for surgical intervention if they are ≥ 5 months post injury. Motor incomplete patients (AIS C or D) will be considered if they are ≥ 1.5 years post injury.
- Patients will require ≥ MRC 4 strength of the muscle supplied by the donor nerve (e.g. brachialis, supinator).
- Finger flexor and extensor strength should be ≤ MRC 1 strength.
- Muscles supplied by the donor nerve, will need to have no or minimal of evidence of lower motor neuron injury as dictated by evidence of fibrillations, positive sharp waves, or moderate or severely decreased recruitment on needle electromyography.
- Those being evaluated for surgery outside nine-months post injury recipient muscles will be required to be free of lower motor neuron pathology.
- Ability to comply and participate in rigorous post-surgical therapy regimen.
Who cannot join
- Comorbidities precluding safe surgery including autonomic/hemodynamic instability, pulmonary instability, active infection, chronic pressure sores or untreated urinary tract infections as determined by physician.
- Simultaneous tendon transfer or tenodesis surgery (which would preclude separation of the effect of nerve transfer alone).
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
This study seeks to evaluate the efficacy of nerve transfers in restoring hand function in patients with cervical spinal injuries.
Read the detailed description
Cervical spinal cord injury is a life-altering injury that results in profound loss of upper limb function. Hand function is essential to basic activities of daily living and consequently has a significant impact on patients' quality of life. Tendon transfers and/or tenodesis have traditionally been used to restore hand function in spinal cord injuries - however, in recent years there is growing interest in the role of nerve transfers as a means of accomplishing this goal. Although preliminary results indicate nerve transfers may be well-suited for patients with spinal cord injury, their long term efficacy has not been demonstrated.
This study seeks to evaluate the efficacy of nerve transfers in restoring hand function in patients with cervical spinal injuries. Eligible patients will receive nerve transfer procedure(s) (e.g. brachialis to anterior interosseous nerve, supinator to posterior interosseous) and will be followed post-operatively to assess for changes in strength, functional independence, and quality of life.
- 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 |
|---|---|---|
| Nerve Transfer | This is an observational study that looks at function and quality of life in patients before and after nerve transfer surgery. 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 - Myometric measures of strength (donor and recipient muscle groups)
Valid and reliable quantitative muscle strength measurement
Measured: Change from baseline at 6, 12, 24, 30 and 36 months post-surgery
Upper extremity function - Manual muscle testing (MRC)
Quantitative assessment of motor function (MRC)
Measured: Change from baseline at 6, 12, 24, 30 and 36 months post-surgery
Upper extremity function - Graded Redefined Assessment of Strength, Sensibility and Prehension test (GRASSP)
Valid, reliable and responsive measure of sensorimotor upper limb impairment specifically designed for patients with cervical SCI
Measured: Change from baseline at 6, 12, 24, 30 and 36 months post-surgery
Upper extremity function - Range of motion
Quantitative assessment of range of motion (degrees)
Measured: Change from baseline at 6, 12, 24, 30 and 36 months post-surgery
Secondary outcomes (4)
Health related quality of life - The Short Form (SF)-36
Valid and responsive measure of quality of life in surgical patients
Measured: Change from baseline at 6, 12, 24, 30 and 36 months post-surgery
Health related quality of life - Spinal Cord Independence Measure (SCIM I)
Disability scale developed to specifically address the ability of SCI patients to perform basic activities of daily living independently
Measured: Change from baseline at 6, 12, 24, 30 and 36 months post-surgery
Health related quality of life - Canadian Occupational Performance Measure (COPM)
Evidence-based outcome measure designed to capture a patient's self-perception of performance in everyday living
Measured: Change from baseline at 6, 12, 24, 30 and 36 months post-surgery
Health related quality of life - Semi-structured interviews
Semi-structured interviews to gain information about satisfaction, acceptability, and the subjective experience of the surgical intervention, therapy, and functional outcome
Measured: Collected at 12 and 24 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 posted10 Aug 2016 (estimated)
- Study startAug 2016
- Primary completion18 Mar 2019 (estimated)
- Study completion18 Mar 2019
Why it stopped: Insufficient patient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for QuadriplegiaStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Neurotrauma Foundation, Canadian Society of Plastic Surgeons, Washington University School of Medicine, Rick Hansen Institute
- Responsible party
- Sponsor
- Investigators
- Kirsty U Boyd, MD, Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02861612
- Sponsor's protocol ID
- 5313
- Status last verified
- Mar 2019
- First submitted
- 13 Jul 2016
- Last updated
- 21 Mar 2019
- 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 25767422
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nerve Transfers to Restore Hand Function in Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT02861612
- Acronym / sponsor ID
- 5313
- 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
- Observational
- Recruitment status
- WithdrawnReason stopped: Insufficient patient recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Ontario Neurotrauma Foundation, Canadian Society of Plastic Surgeons, Washington University School of Medicine, Rick Hansen Institute
- Study start
- Aug 2016
- Primary completion
- 18 Mar 2019 (estimated)
- Study completion
- 18 Mar 2019 (actual)
- First posted
- 10 Aug 2016 (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.
This study seeks to evaluate the efficacy of nerve transfers in restoring hand function in patients with cervical spinal injuries.
Detailed description
Cervical spinal cord injury is a life-altering injury that results in profound loss of upper limb function. Hand function is essential to basic activities of daily living and consequently has a significant impact on patients' quality of life. Tendon transfers and/or tenodesis have traditionally been used to restore hand function in spinal cord injuries - however, in recent years there is growing interest in the role of nerve transfers as a means of accomplishing this goal. Although preliminary results indicate nerve transfers may be well-suited for patients with spinal cord injury, their long term efficacy has not been demonstrated.
This study seeks to evaluate the efficacy of nerve transfers in restoring hand function in patients with cervical spinal injuries. Eligible patients will receive nerve transfer procedure(s) (e.g. brachialis to anterior interosseous nerve, supinator to posterior interosseous) and will be followed post-operatively to assess for changes in strength, functional independence, and quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nerve Transfer | – | Procedure: Nerve Transfer SurgeryThis is an observational study that looks at function and quality of life in patients before and after nerve transfer surgery. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Any patients with cervical spinal cord injury and upper extremity dysfunction who are medically stable, residents of Canada, willing and able to be assessed at the The Ottawa Hospital are potential participants.
Key inclusion criteria (6 listed)
- Patients with a spinal cord injury AIS level C5 to C7. Those with motor complete injuries (AIS A or B) will be considered for surgical intervention if they are ≥ 5 months post injury. Motor incomplete patients (AIS C or D) will be considered if they are ≥ 1.5 years post injury.
- Patients will require ≥ MRC 4 strength of the muscle supplied by the donor nerve (e.g. brachialis, supinator).
- Finger flexor and extensor strength should be ≤ MRC 1 strength.
- Muscles supplied by the donor nerve, will need to have no or minimal of evidence of lower motor neuron injury as dictated by evidence of fibrillations, positive sharp waves, or moderate or severely decreased recruitment on needle electromyography.
- Those being evaluated for surgery outside nine-months post injury recipient muscles will be required to be free of lower motor neuron pathology.
Key exclusion criteria (2 listed)
- Comorbidities precluding safe surgery including autonomic/hemodynamic instability, pulmonary instability, active infection, chronic pressure sores or untreated urinary tract infections as determined by physician.
- Simultaneous tendon transfer or tenodesis surgery (which would preclude separation of the effect of nerve transfer alone).
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 | Nerve Transfer |
Primary outcome
Upper extremity function - Myometric measures of strength (donor and recipient muscle groups)
Time frame: Change from baseline at 6, 12, 24, 30 and 36 months post-surgery
Valid and reliable quantitative muscle strength measurement
Upper extremity function - Manual muscle testing (MRC)
Time frame: Change from baseline at 6, 12, 24, 30 and 36 months post-surgery
Quantitative assessment of motor function (MRC)
Upper extremity function - Graded Redefined Assessment of Strength, Sensibility and Prehension test (GRASSP)
Time frame: Change from baseline at 6, 12, 24, 30 and 36 months post-surgery
Valid, reliable and responsive measure of sensorimotor upper limb impairment specifically designed for patients with cervical SCI
Upper extremity function - Range of motion
Time frame: Change from baseline at 6, 12, 24, 30 and 36 months post-surgery
Quantitative assessment of range of motion (degrees)
4 secondary outcomes
Health related quality of life - The Short Form (SF)-36
Time frame: Change from baseline at 6, 12, 24, 30 and 36 months post-surgery
Health related quality of life - Spinal Cord Independence Measure (SCIM I)
Time frame: Change from baseline at 6, 12, 24, 30 and 36 months post-surgery
Health related quality of life - Canadian Occupational Performance Measure (COPM)
Time frame: Change from baseline at 6, 12, 24, 30 and 36 months post-surgery
Health related quality of life - Semi-structured interviews
Time frame: Collected at 12 and 24 months post-surgery.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
- Background: 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.
- Background: 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.
- Individual participant dataSharing planned: No
Related trials for Quadriplegia
Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
RecruitingPhase 3
A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury
Chronic Spinal Cord Injury
Recruiting
Transcutaneous Tibial Nerve Stimulation in Acute Spinal Cord Injury
Spinal Cord Injury, Acute
Recruiting
Acute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury
Fecal Incontinence
RecruitingPhase 2/3
Pilot Study of Galantamine to Treat Metabolic Syndrome in People With Chronic Traumatic Spinal Cord Injury (SCI)
Spinal Cord Injury, Traumatic Spinal Cord Injury
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.
Kirsty U Boyd, MD principal investigator
The Ottawa Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quadriplegia and Spinal Cord Diseases, run by Ottawa Hospital Research Institute at 2 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 6 inclusion and 2 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: withdrawn, as of the sponsor's last update on 21 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study was withdrawn before enrolling participants, so there are no results.
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 - Myometric measures of strength (donor and recipient muscle groups) (time frame: Change from baseline at 6, 12, 24, 30 and 36 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?
On the ClinicalTrials.gov record for NCT02861612, which also lists 2 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 21 Mar 2019.