Restoring Hand Function Using Nerve Transfers in Persons With Spinal Cord Injury
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Change in upper motor strength
Study Overview
Brief Summary
Nerve Transfer surgery can provide improved hand function following cervical spinal cord injuries
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Arms & Interventions
Nerve Transfer
Surgical - Nerve transfers for patients with stable cervical spinal cord injuries
Intervention: Nerve Transfer (Procedure)
Outcomes
Primary Outcomes
Change in upper motor strength
Time Frame: 48 months
Patients motor strength will be assessed over 48 months of clinical follow-up with conventional manual motor testing
Secondary Outcomes
- Change in Michigan Hand Questionnaire (MHQ)(48 months)
- Change in Disabilities of Arm, Shoulder, and Hand (DASH) scores(48 months)
- Change in Short Form 36 (SF-36) scores(48 months)