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

Launched by STANFORD UNIVERSITY · Aug 3, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring whether using electrical stimulation during and after nerve transfer surgery can help improve hand function and reduce pain for patients with cervical spinal cord injuries. Specifically, the study aims to find out if brief electrical stimulation during the surgery and a temporary device to stimulate the nerves afterward can lead to better outcomes than standard surgery alone.

To participate, individuals must be between 18 and 65 years old and have a cervical spinal cord injury that has left them without hand function. Participants will undergo a thorough pre-surgery assessment and then have nerve transfer surgery, which aims to restore movement in their hands. They will receive the usual care along with the added electrical stimulation treatments and will follow up with their surgeon at several points after the surgery to track their progress. Importantly, participants will need to have some support at home to attend follow-up visits and be able to read and write in English to complete necessary questionnaires.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Cervical spinal cord injury, ASIA A or ASIA B
• • 2. International Standards for Neurological Classification of Spinal Cord Injury neurological level of injury C6 or C7
• • 3. 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 recipient
• • 4. Age 18-65 years
• • 5. Mentally and physically able to comply with evaluations and assessments
• • 6. 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 injury
• • 7. 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 months
• • 10. Able to read and write in English at a level necessary to complete the questionnaires
• Exclusion Criteria:
• • 1. Contraindication to electrical stimulation, including any implanted electronic device such as a pacemaker or intrathecal drug delivery pump
• • 2. Active infection at the operative site or systemic infection
• • 3. Active malignancy
• • 4. Pregnancy
• • 5. Joint contractures or limited passive range of motion that would limit recovery of function
• • 6. Lack of appropriate social support and/or infrastructure to commit to scheduled follow-up visits
• • 7. Previous tendon transfer or other surgery for restoration of function following cervical spinal cord injury
• • 8. Planned tendon transfer surgery or other surgery for restoration of function following cervical spinal cord injury