Nerve Transfers to Restore Hand Function in Spinal Cord Injury

This study seeks to evaluate the efficacy of nerve transfers in restoring hand function in patients with cervical spinal injuries.

Study Overview

• Status: Withdrawn
• Conditions: Spinal Cord Diseases; Spinal Cord Injuries; Quadriplegia
• Intervention / Treatment: Procedure: Nerve Transfer Surgery

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 Type: Observational

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1Y 4E9
      • The Ottawa Hospital
• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Nerve Transfer; This is an observational study that looks at function and quality of life in patients before and after nerve transfer surgery.	Procedure: Nerve Transfer Surgery; Unilateral surgery will be performed under general non-paralytic anesthesia and no-tourniquet conditions to allow for responsive nerve simulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Upper extremity function - Myometric measures of strength (donor and recipient muscle groups)	Valid and reliable quantitative muscle strength measurement	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)	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	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)	Change from baseline at 6, 12, 24, 30 and 36 months post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health related quality of life - The Short Form (SF)-36	Valid and responsive measure of quality of life in surgical patients	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	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	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	Collected at 12 and 24 months post-surgery.

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Collaborators: Washington University School of Medicine; Ontario Neurotrauma Foundation; Rick Hansen Institute; Canadian Society of Plastic Surgeons
• Investigators: Principal Investigator: Kirsty U Boyd, MD, The Ottawa Hospital

Publications and helpful links

General 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.
• Fox 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Anticipated): March 18, 2019
• Study Completion (Actual): March 18, 2019

Study Registration Dates

• First Submitted: July 13, 2016
• First Submitted That Met QC Criteria: August 4, 2016
• First Posted (Estimate): August 10, 2016

Study Record Updates

• Last Update Posted (Actual): March 21, 2019
• Last Update Submitted That Met QC Criteria: March 19, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: quality of life; nerve transfer; quadriplegia; hand; upper extremity; peripheral nerves; surgical procedures, operative
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Trauma, Nervous System; Paralysis; Wounds and Injuries; Spinal Cord Diseases; Spinal Cord Injuries; Quadriplegia
• Other Study ID Numbers: 5313

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO