Upper Extremity Surgery in Spinal Cord Injury
Condition: Quadriplegia; Spinal Cord Diseases; Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries; Quadriplegia; Spinal Cord Diseases; Wounds and Injuries
Study type: Interventional

Summary: 
      The goal of the investigators work is to establish how nerve transfers can be best used to
      improve upper extremity function in patients with cervical level spinal cord injury (SCI).
      The investigators' hypothesis is that nerve transfers are safe and effective and will improve
      function and quality of life in patients with loss of upper function due to spinal cord
      injury. The investigators plan on looking at upper limb function, and health-related quality
      of life in patients before and after surgery to better understand how patients benefit from
      these treatments.

      A nerve transfer procedure can be used to rewire the system to make some muscles work again
      following SCI. The nerve transfer procedure (which is done in the arm and not at the level of
      the spinal cord) can be used to bypass the damaged area and to deliver a signal from the
      brain to a muscle that became disconnected following that injury. A donor nerve is taken from
      another muscle whose use is not essential and then transferred to help in providing more a
      more critical function.

      For example, one type of nerve transfer is done to restore the lost ability to pinch or grasp
      small objects between the fingers that occurs in many patients with cervical SCI. In this
      surgery, a donor nerve that normally helps flex the elbow. This nerve can be used because the
      biceps muscle is also working to flex the elbow. This donor nerve is cut and re-attached to
      the nerve going to muscles in the forearm that provide pinch by bending the tips of the thumb
      and index finger.

      Because the nerve transfer procedure involves cutting and reattaching nerve and muscle
      tissues, time is required to regenerate working connections between the nerves and muscle as
      well as to allow the brain to relearn how to use and strengthen that muscle.
    

Detailed description: 
      Background/Readiness

      Cervical spinal cord injury (SCI) is a life altering injury that results in profound loss of
      upper limb function. Nerve transfer surgery has transformed the field of peripheral nerve
      injury surgery, allowing remarkable restoration of upper limb motor function. The
      investigators expanded use of nerve transfer surgery to cervical SCI patients and are the
      first center to successfully restore volitional hand function in a patient with a C7 motor
      level injury (now 3 years post-surgery). Results in 7 more patients show early functional
      gains at 3-6 months post-surgery (most gains are expected at 12 months and these patients are
      still early in their course). The proposed study will obtain formative outcomes data from a
      pilot investigation of nerve transfer surgery to restore upper extremity function in patients
      with cervical SCI.

      Upper extremity and hand function is essential to basic activities of daily living and
      independence; patients with cervical SCI rate this as more important than walking and sexual
      performance. Restoration of critical upper extremity and hand function requires the unique
      expertise and technical skill of hand surgeons; traditionally tendon transfer/tenodesis are
      used. Although studies report reasonable outcomes in SCI patients for this procedure, use is
      limited particularly in the US.

      Nerve transfers offer an alternative and promising approach. In peripheral nerve injury,
      nerve transfers are well-established, safe and are often the treatment of choice. A nerve
      transfer uses an expendable donor nerve and coapts this to a nonfunctional recipient nerve to
      restore volitional motor function. Since a nerve transfer reinnervates the musculotendinous
      unit responsible for the absent but desired function, this procedure: 1) does not have the
      biomechanical limitations of tendon transfers; 2) can use expendable donor nerves whose
      muscles cannot be used for tendon transfer (i.e. the brachialis); and 3) a single donor nerve
      can provide more than one function via reinnervation of multiple muscles. Most importantly
      for SCI patient acceptability, nerve transfers do not require prolonged periods of
      immobilization; early resumption of activity is encouraged.

      Preliminary Data:

      Case reports offer early evidence that this novel application of nerve transfers may be a
      better alternative to tendon transfers in SCI. Based on our extensive experience with nerve
      transfers in peripheral nerve injury, we expect this approach will have a profound impact on
      improving function, independence and health-related quality of life (QoL).

      The purpose of this study is to provide evidence on the feasibility, safety, and outcomes of
      nerve transfers in SCI patients via systematically collected data and to evaluate patients'
      perspective of the benefits and disadvantages of nerve transfers. These data are vital for
      patient selection, patient and surgeon education, and adaptation of this well-established
      technique to this unique and traditionally underserved patient population.

      Hypothesis and Approach:

      Hypothesis: Nerve transfers are safe, effective procedures that have a role in the treatment
      armamentarium of cervical SCI associated upper extremity dysfunction.

      Aim 1: To document the safety, time course and improvement (potential for nerve transfers to
      improve functional outcomes) by assessing pre and post-operative function.

      Aim 2: To evaluate the feasibility and suitability of nerve transfers through
      multidisciplinary evaluation, electrodiagnostic testing, ultrasound, and nerve specimen
      examination and correlation with the clinical outcome.

      Aim 3: To assess patient satisfaction with and acceptability for this treatment by use of
      semi-structured patient interviews.
    

Intervention name(s): Nerve Transfer Surgery
Intervention type(s): Procedure
Intervention description(s): Unilateral surgery will be performed under general non-paralytic anesthesia and no-tourniquet conditions to allow for responsive nerve simulation.
Intervention model: Single Group Assignment
Intervention model description: Subjects will undergo the following:
A full International Standards for Neurological Classification of SCI exam will be completed to determine exact function and type of spinal cord injury.
A phone interview will be completed at both preoperative and postoperative time points.
Quality of life before and after surgical intervention will be derived from standardized questionnaires: Spinal Cord Independence Measure (SCIM), SF-36, Novak scale, and pain questionnaires.
Additional qualitative and quantitative data on donor and recipient nerve function and tissue will be derived from preoperative electrodiagnostic studies.
Specimens of the donor and recipient nerve are collected for histologic analysis during the operative procedure. Those trimmed nerve specimens are then analyzed for clinical purposes to give patients an idea of expected outcome in a more timely fashion.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: peripheral nerves; quadriplegia; nerve transfer; surgical procedures, operative; hand; upper extremity; quality of life