Nerve Transfer to Improve Function in High Level Tetraplegia

Wilson Z. Ray

Status: Enrolling

Conditions: Tetraplegia; Cervical Spinal Cord Injury

Study type: Observational

Funder types: Other

Identifiers

NCT06288763

CDMRP-eBRAP-SC220192

Details and patient eligibility

About

The goal of this observational study is to determine if nerve transfer surgeries improve upper extremity function and quality of life in patients with a high level cervical spinal cord injury.

Participants will:

• undergo standard of care pre- and post-op testing and study exams
• complete pre- and post-questionnaires
• undergo standard of care nerve transfer surgeries
• follow-up with surgeon at 6/12/18/24/36 and potentially at 48 months
• attend therapy at local therapist for up to 2 years postop.

Full description

Restoration of function in patients with high tetraplegia has been an elusive clinical challenge. There is a critical need to find an effective reconstructive therapy/procedure which improves the upper extremity function in patients with high tetraplegia.

One pure motor nerve - spinal accessory nerve (SAN) remains a viable donor in high tetraplegia patients to successfully restore elbow flexion or extension. Elbow function can provide profound independence in mobility, ventilator management and may broaden the application of assistive therapies.

The two objectives of this study are:

• Determine if SAN nerve transfer surgery can improve the reinnervation of bicep or tricep muscles in high tetraplegia patients.
• Determine if SAN nerve transfer surgery can reanimate upper arm function and improve functional independence in patients with high tetraplegia.

Study Activities (including standard of care (SOC))

• Electrodiagnosis pre-op (SOC)
• Upper extremity maximum muscle testing (SOC)
• Questionnaires (SOC and study-related (SR))
• Exams by a study therapist (SR)
• Neurological exam - ISNCSCI - (SOC)
• Nerve Transfer Surgery to be determined by surgeon (SOC)
• Follow-up visits with surgeon at 6/12/18/24/36 and potentially 48 months
• post-op electrodiagnostic testing (SR)
• post-op upper extremity maximum muscle testing (SOC)
• post-op questionnaires
• post-op therapy exams (SR)

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18-80 years of age
• High cervical SCI (motor level C1-C4)
• Motor complete SCI AIS grade A-B
• Plateaued spontaneous recovery for at least 6 months of non-operative therapy
• SCI greater than 6 months and fewer than 60 months since injury
• At least MRC 4/5 donor strength
• Mentally and physically willing and able to comply with evaluations

Exclusion criteria

• Active infection at the operative site or systemic infection
• Any return or ongoing recovery of distal motor function
• Significant joint contractures and/or limitations in passive range of motion in the arm
• Mentally or physically compromised making it impossible to complete study activities
• Immunologically suppressed
• Currently undergoing long-term steroid therapy
• Active malignancy
• Pregnancy