Nerve Transfers to Restore Hand Function in Spinal Cord Injury

NCT ID: NCT02861612

Last Updated: 2019-03-21

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2019-03-18

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.

Conditions

Quadriplegia; Spinal Cord Diseases; Spinal Cord Injuries

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Nerve Transfer

This is an observational study that looks at function and quality of life in patients before and after nerve transfer surgery.

Nerve Transfer Surgery

Intervention Type: PROCEDURE

Unilateral surgery will be performed under general non-paralytic anesthesia and no-tourniquet conditions to allow for responsive nerve simulation.

Interventions

Nerve Transfer Surgery

Unilateral surgery will be performed under general non-paralytic anesthesia and no-tourniquet conditions to allow for responsive nerve simulation.

Intervention Type: PROCEDURE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ontario Neurotrauma Foundation

OTHER

Sponsor Role: collaborator

Canadian Society of Plastic Surgeons

OTHER

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: collaborator

Rick Hansen Institute

OTHER

Sponsor Role: collaborator

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kirsty U Boyd, MD

Role: PRINCIPAL_INVESTIGATOR

The Ottawa Hospital

Locations

Washington University School of Medicine

St Louis, Missouri, United States

The Ottawa Hospital

Ottawa, Ontario, Canada

Countries

United States; Canada

References

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.

Reference Type: BACKGROUND

PMID: 26397252 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25767422 (View on PubMed)

Other Identifiers

5313

Identifier Type: -

Identifier Source: org_study_id