Nerve Transfers to Restore Hand Function in Spinal Cord Injury
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Quadriplegia
- Sponsor
- Ottawa Hospital Research Institute
- Locations
- 2
- Primary Endpoint
- Upper extremity function - Range of motion
- Status
- Withdrawn
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with a spinal cord injury AIS level C5 to C
- •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.
Exclusion Criteria
- •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).
Outcomes
Primary Outcomes
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)
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 - 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
Secondary Outcomes
- Health related quality of life - Canadian Occupational Performance Measure (COPM)(Change from baseline at 6, 12, 24, 30 and 36 months post-surgery)
- Health related quality of life - Semi-structured interviews(Collected at 12 and 24 months post-surgery.)
- Health related quality of life - Spinal Cord Independence Measure (SCIM I)(Change from baseline at 6, 12, 24, 30 and 36 months post-surgery)
- Health related quality of life - The Short Form (SF)-36(Change from baseline at 6, 12, 24, 30 and 36 months post-surgery)