Restoring Hand Function Utilizing Nerve Transfers in Persons With Cervical Spinal Cord Injuries

The University of Texas System (UT)

Status: Terminated

Conditions: Traumatic Spinal Cord Compression; Spinal Cord Injuries; Cervical Spinal Cord Injury

Treatments: Procedure: Upper extremity nerve transfer surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT03451474

HSC-MS-17-0081

Details and patient eligibility

About

The primary objective of this study is to evaluate the safety and efficacy of nerve transfer surgery for restoring hand function as a therapy for patients with cervical spinal cord injury.

Enrollment: 3 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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
• >6 months post-injury
• International Classification of Surgery of the Hand in Tetraplegia (ICSHT) category 0-4
• Cervical spinal cord injury resulting in arm & hand functional impairment, with at least preserved elbow flexion
• Physically and mentally willing and able to comply with study protocol
• Lives in the immediate area and has no plans to relocate
• Provides informed consent and HIPAA release of medical information

Exclusion criteria

• Active infection
• Any return or ongoing clinical recovery of distal motor function within 6 months after injury
• Physically/mentally compromised
• Systemic disease that would affect the patient's welfare or the research study
• Immunologically suppressed or immunocompromised
• Currently undergoing long-term steroid therapy
• Active malignancy
• Pending litigation or receiving Workers Compensation related to injury or accident
• Pregnancy
• Significant contractures and/or limitations in passive range of motion in the arm or hand
• Poorly controlled upper extremity spasticity
• Uncontrolled pain or hypersensitivity
• Previous or current injury preventing use of tendon transfers to restore upper extremity function
• History of brachial plexus injury or systemic neuropathic process
• In the opinion of the Principal Investigator the subject would not be a candidate for the procedure

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Upper extremity nerve transfer surgery

Experimental group

Description:

Upper extremity nerve transfer surgery is a surgical procedure where axons from an intact, functioning upper extremity peripheral nerve are moved to a target muscle that demonstrates significant weakness or paralysis as a result of spinal cord injury. After allowing time for recovery from surgery and for nerve growth to occur, the patient undergoes hand/occupational therapy in order to retrain motor skills.

Treatment:

Procedure: Upper extremity nerve transfer surgery