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Nerve Transfers to Restore Hand Function in Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT02861612
Recruitment Status : Withdrawn (Insufficient patient recruitment)
First Posted : August 10, 2016
Last Update Posted : March 21, 2019
Sponsor:
Collaborators:
Ontario Neurotrauma Foundation
Canadian Society of Plastic Surgeons
Washington University School of Medicine
Rick Hansen Institute
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Quadriplegia Spinal Cord Diseases Spinal Cord Injuries 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.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Nerve Transfers to Restore Hand Function in Spinal Cord Injury
Study Start Date : August 2016
Estimated Primary Completion Date : March 18, 2019
Actual Study Completion Date : March 18, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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

  2. 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)

  3. 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

  4. 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)


Secondary Outcome Measures :
  1. Health related quality of life - The Short Form (SF)-36 [ Time Frame: Change from baseline at 6, 12, 24, 30 and 36 months post-surgery ]
    Valid and responsive measure of quality of life in surgical patients

  2. Health related quality of life - Spinal Cord Independence Measure (SCIM I) [ Time Frame: 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

  3. Health related quality of life - Canadian Occupational Performance Measure (COPM) [ Time Frame: 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

  4. Health related quality of life - Semi-structured interviews [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02861612


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Canada, Ontario
The Ottawa Hospital
Ottawa, Ontario, Canada, K1Y 4E9
Sponsors and Collaborators
Ottawa Hospital Research Institute
Ontario Neurotrauma Foundation
Canadian Society of Plastic Surgeons
Washington University School of Medicine
Rick Hansen Institute
Investigators
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Principal Investigator: Kirsty U Boyd, MD The Ottawa Hospital
Publications:
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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT02861612    
Other Study ID Numbers: 5313
First Posted: August 10, 2016    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ottawa Hospital Research Institute:
peripheral nerves
quadriplegia
nerve transfer
surgical procedures, operative
hand
upper extremity
quality of life
Additional relevant MeSH terms:
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Spinal Cord Injuries
Quadriplegia
Spinal Cord Diseases
Wounds and Injuries
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Paralysis
Neurologic Manifestations