Nerve Transfers to Restore Hand Function in Spinal Cord Injury

NCT02861612 | Withdrawn

• 1 other identifier: 5313
• Study Type: observational
• Target: N/A
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Quadriplegia; Spinal Cord Diseases; Spinal Cord Injuries

Keywords

peripheral nerves; quadriplegia; nerve transfer; surgical procedures, operative; hand; upper extremity; quality of life

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Health related quality of life - The Short Form (SF)-36

  Change from baseline at 6, 12, 24, 30 and 36 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 - 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.

Study Arms (1)

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

Interventions

Nerve Transfer Surgery PROCEDURE

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

Nerve Transfer

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Ontario Neurotrauma Foundation: collaborator
• Canadian Society of Plastic Surgeons: collaborator
• Washington University School of Medicine: collaborator
• Rick Hansen Institute: collaborator

Study Sites (2)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

The Ottawa Hospital

Ottawa, Ontario, K1Y 4E9, Canada

Location

Related Publications (2)

• 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.

  PMID: 26397252 BACKGROUND

• 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.

  PMID: 25767422 BACKGROUND

MeSH Terms

Conditions

Quadriplegia; Spinal Cord Diseases; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Kirsty U Boyd, MD

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2016
• First Posted: August 10, 2016
• Study Start: August 1, 2016
• Primary Completion: March 18, 2019
• Study Completion: March 18, 2019
• Last Updated: March 21, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (1)