Nerve Transfers Plus Electrical Stimulation to Improve Hand Function in Cervical Spinal Cord Injury

Trial ID or NCT#

NCT06541041

Status

recruiting iconRECRUITING

Purpose

The goal of this prospective observational study is to determine whether brief intraoperative electrical stimulation and temporary postoperative electrical stimulation improve motor and/or pain outcomes for patients with cervical spinal cord injury undergoing standard of care nerve transfer surgery to improve hand function. The main hypotheses include: Hypothesis #1: Brief intraoperative electrical stimulation of the donor nerves will result in improved motor outcomes (hand function) compared to standard nerve transfer surgery in patients with cervical spinal cord injuries. Hypothesis #2: Placement of a temporary peripheral nerve stimulator for 60 days of postoperative electrical stimulation will result in improved pain outcomes compared to standard nerve transfer surgery in patients with cervical spinal cord injuries. Researchers will prospectively enroll patients with cervical spinal cord injury and no hand function who will undergo standard of care nerve transfer surgery combined with standard of care brief intraoperative electrical stimulation and temporary postoperative electrical stimulation. Motor and pain outcomes will be compared to a retrospective group of patients who underwent nerve transfer surgery without intraoperative or postoperative electrical stimulation. Participants will receive standard medical care (nothing experimental) as part of this study. Participants will: * Have a preoperative assessment including physical examination, electrodiagnostic studies, functional electrical stimulation, and will complete questionnaires assessing function and quality of life * Agree upon a surgical plan, including the specific nerve transfers to be performed and whether to include brief intraoperative electrical stimulation and/or temporary postoperative electrical stimulation before being considered for enrollment in the study * Will undergo standard of care nerve transfer surgery, with at least one nerve transfer targeting improvement in hand function and will receive brief intraoperative electrical stimulation of the donor nerves and placement of a temporary peripheral nerve stimulator * Will follow-up with the surgeon 3, 6, 12, 24, and 36 months after the surgery * Will have a physical examination and will complete questionnaires at the postoperative visits * Will participate in hand therapy following the operation * Will be eligible for placement of a permanent peripheral nerve stimulator, depending on response to the temporary peripheral nerve stimulator.

Official Title

Evaluation of Electrical Stimulation During Nerve Transfer Surgery for Cervical Spinal Cord Injury

Eligibility Criteria

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes
Inclusion Criteria:
  1. 1. Cervical spinal cord injury, ASIA A or ASIA B2. International Standards for Neurological Classification of Spinal Cord Injury neurological level of injury C6 or C73. Agreed upon surgical plan includes at least 1 nerve transfer targeting finger flexion with the anterior interosseous nerve as the recipient and at least 1 nerve transfer targeting finger extension with the posterior interosseous nerve as the recipient4. Age 18-65 years5. Mentally and physically able to comply with evaluations and assessments6. Upper motor neuron pattern of injury in the recipient nerve with planned surgery 36 months or less from the time of injury OR lower motor neuron pattern of injury in the recipient nerve with planned surgery 9 months or less from the time of injury7. Muscle grade at least 4+/5 on the Medical Research Council (MRC) scale in the territory of the donor nerve(s)8. Stable function for at least 3 months (i.e., no ongoing recovery)9. Non-operative rehabilitation for at least 3 months10. Able to read and write in English at a level necessary to complete the questionnaires
Exclusion Criteria:
  1. 1. Contraindication to electrical stimulation, including any implanted electronic device such as a pacemaker or intrathecal drug delivery pump2. Active infection at the operative site or systemic infection3. Active malignancy4. Pregnancy5. Joint contractures or limited passive range of motion that would limit recovery of function6. Lack of appropriate social support and/or infrastructure to commit to scheduled follow-up visits7. Previous tendon transfer or other surgery for restoration of function following cervical spinal cord injury8. Planned tendon transfer surgery or other surgery for restoration of function following cervical spinal cord injury

Investigator(s)

Thomas J. Wilson
Thomas J. Wilson
Peripheral nerve surgeon, Neurosurgeon
Clinical Professor, Neurosurgery

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Contact

Thomas J Wilson, MD, MPH
650-723-6469