Nerve Transfers to Restore Hand Function in Spinal Cord Injury

Withdrawn

• Conditions: Quadriplegia; Spinal Cord Diseases; Spinal Cord Injuries
• Interventions: Procedure: Nerve Transfer Surgery

• Registration Number: NCT02861612
• Lead Sponsor: Ottawa Hospital Research Institute

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.

Study Timeline

• Study First Submitted: 2016-07-13
• Study Start: 2016-08
• Study First Submitted QC: 2016-08-04
• Study First Posted: 2016-08-10
• Status Verified: 2019-03
• Primary Completion: 2019-03-18
• Study Completion: 2019-03-18
• Last Update Submitted: 2019-03-19
• Last Update Posted: 2019-03-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• 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.

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Nerve Transfer	Nerve Transfer Surgery	This is an observational study that looks at function and quality of life in patients before and after nerve transfer surgery.

Primary Outcome Measures

Name	Time	Method
Upper extremity function - Range of motion	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)	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)	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)	Change from baseline at 6, 12, 24, 30 and 36 months post-surgery	Valid and reliable quantitative muscle strength measurement

Secondary Outcome Measures

Name	Time	Method
Health related quality of life - Canadian Occupational Performance Measure (COPM)	Change from baseline at 6, 12, 24, 30 and 36 months post-surgery	Evidence-based outcome measure designed to capture a patient's self-perception of performance in everyday living
Health related quality of life - Semi-structured interviews	Collected at 12 and 24 months post-surgery.	Semi-structured interviews to gain information about satisfaction, acceptability, and the subjective experience of the surgical intervention, therapy, and functional outcome
Health related quality of life - Spinal Cord Independence Measure (SCIM I)	Change from baseline at 6, 12, 24, 30 and 36 months post-surgery	Disability scale developed to specifically address the ability of SCI patients to perform basic activities of daily living independently
Health related quality of life - The Short Form (SF)-36	Change from baseline at 6, 12, 24, 30 and 36 months post-surgery	Valid and responsive measure of quality of life in surgical patients

Trial Locations

Locations (2)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

The Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada