Nerve Transfer After Spinal Cord Injuries

Study Overview
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Brief Summary
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Nerve Transfer surgery can provide improved hand function following cervical spinal cord injuries

Detailed Description
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Current treatment strategies of acute cervical spinal cord injuries remain limited. Treatment options that provide meaningful improvements in patient quality of life and long-term functional independence will provide a significant public health impact. Specific Aim: Measure the efficacy of nerve transfer surgery in the treatment of patients with complete cervical spinal cord injuries with no hand function. Optimize the efficiency of nerve transfer surgery by evaluating patient outcomes in relation to patient selection and optimal timing the the surgery. Hypothesis: Peripheral nerve transfers in patients with spinal cord injuries will improve hand function and provide improvement in patient quality of life and functional independence.

Official Title
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Restoring Hand Function Using Nerve Transfers in Persons With Spinal Cord Injury

Conditions
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Spinal Cord Injury

Intervention / Treatment
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* Procedure: Nerve Transfer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-65 years of age Informed Consent Document (ICD) signed by patient Cervical spinal cord injury resulting in arm & hand functional impairment, with at least preserved elbow function International Classification of Surgery of the Hand in Tetraplegia (ICSHT) category 0 - 4 Patients with a stable American Spinal Injury Association (ASIA) grade of A, B, or C, or with a diagnosis of central cord syndrome, showing minimal to no evidence of functional improvement in motor examination after at least 6 months of non-operative therapy post-injury Appropriate candidate for nerve transfer study Willing and able to comply with the study protocol < 48 months from injury Exclusion Criteria: Active infection at the operative site or systemic infection Any return or ongoing clinical recovery of distal motor function within 6 months after injury Physically or mentally compromised Currently undergoing long-term steroid therapy Significant joint contractures and/or limitations in passive range of motion in the arm or hand Active malignancy Systemic disease that would affect the patient's welfare or the research study Pregnant Immunologically suppressed or immunocompromised Significant pain or hypersensitivity Previous or current injury preventing use of tendon transfers to restore upper extremity function Affective disorder of a degree that would make outcome assessment and study participation difficult History of brachial plexus injury or systemic neuropathic process

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nerve Transfer<br>Surgical - Nerve transfers for patients with stable cervical spinal cord injuries | Procedure: Nerve Transfer<br>* A nerve transfer procedure will be individualized to each patient's functional deficit.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in upper motor strength | Patients motor strength will be assessed over 48 months of clinical follow-up with conventional manual motor testing | 48 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Disabilities of Arm, Shoulder, and Hand (DASH) scores | The change in DASH scores will be followed over time and assessed pre-operatively, 6,12, 18, 24, 36 and 48 months post-operatively. | 48 months | 
| Change in Short Form 36 (SF-36) scores | The change in SF-36 scores will be followed over time and assessed pre-operatively, 6, 12, 18, 24. 36 and 48 months post-operatively. | 48 months | 
| Change in Michigan Hand Questionnaire (MHQ) | The change in MHQ will be followed over time and assessed pre-operatively, 6, 12, 18, 24, 36 and 48 months post-operatively. | 48 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal cord injury, nerve transfer, tetraplegia, quadriplegia