Nerve Transfer After Spinal Cord Injury- Multi-center

The Washington University

Status: Active, not recruiting

Conditions: Quadriplegia Flaccid; Tetraplegia; Spinal Cord Injuries

Treatments: Procedure: Surgery/Occupational Therapy

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04023591

SC180063

Details and patient eligibility

About

Current treatment strategies of acute cervical spinal cord injuries remain limited. Treatment options that provide meaningful improvements in patient quality of like and long-term functional independence will provide a significant public health impact. Specific aim: Measure the efficacy of nerve transfer surgery in the treatment of patients with complete spinal cord injuries with no hand function. Optimize the efficiency of nerve transfer surgery by evaluating patient outcomes in relation to patient selection and quality of life and functional independence.

Full description

Study Design and Feasibility: A prospective multi-institutional non-randomized single arm design will be utilized. Seventy subjects with cervical ASIA A-B (International Standards for Neurological Classification of Spinal Cord Injury) SCI and hand function impairment that fit the International Classification for Surgery of the Hand 0-4 will be identified. Only patients with stable ASIA scores and no evidence of functional improvement in motor or sensory examination for at least 3 months will be recruited. All patients will undergo Electromyography (EMG) and nerve conduction studies (NCS) to verify intact innervation (normal compound muscle action potentials (CMAPs)) to the paralyzed target muscles below the level of injury. Functional electrical stimulation (FES) will be used to verify loss of lower motor neuron function in key muscle groups in the zone of injury and help differentiate those muscle with intact connections to preserve anterior horn cells. Only those patients with clinically normal, Medical Research Council (MRC) muscle grade 5/5 donor (axonal donor) function will be enrolled.

Outcome Measures Primary Outcome Measures: Pre- and Post-operative upper motor strength. (Manual motor testing & Hand Held Dynamometry) Secondary Outcome Measures: Disabilities of the Arm, Shoulder, and Hand (DASH), Michigan Hand Questionnaire (MHQ), Spinal Cord Injury Quality of Life (SCIQOL), GRASSP test (pre-operative, post-operatively - 6 months, 12 months, and 24 months, 36 months and 48 months), rates of intraoperative and post-operative complications, and rates of reoperation.

Rehabilitation and hand therapy are critical components of motor re-education following nerve transfers. Cortical plasticity and motor remapping occurs following nerve transfers allowing independent functional control of the recipient muscles. All patients will begin rehabilitation and hand therapy beginning 2 weeks after surgery. They undergo one hour of hand therapy and occupational therapy for motor re-education once to twice a week for 48 months following surgery. Rehabilitation will be phased to early and late - added exercises focusing on co-contraction, repetition, and range of motion will be included as home therapy.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. Age 18-65, inclusive
2. At least 3 months of non-operative rehab therapy
3. Mentally and physically willing and able to comply with evaluations
4. Less than 36 months post-injury
5. Stable ASIA scores with no evidence of functional improvement in motor or sensory examination for at least 3 months
6. ASIA A or B determined by the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
7. EMG/NCS verifies intact innervation (normal CMAPs) to the paralyzed target muscles below the level of injury
8. Functional electrical stimulation (FES) will be performed. Subject must have clinically normal MRC grade 5/5 donor (axonal) function
9. Injury Level C4-C8

Exclusion Criteria

1. Active infection at the operative site or systemic infection
2. Any return or ongoing clinical recovery of distal motor function
3. Mentally or physically compromised that will prevent them from complying with evaluations.
4. Immunologically suppressed
5. Currently undergoing long-term steroid therapy
6. Active malignancy
7. Pregnant
8. Significant joint contractures and/or limitations in passive range of motion in the arm or hand, per treating surgeon's discretion
9. Lack of appropriate social support and/or infrastructure to commit to scheduled follow-up visits.
10. Patients who are planning on undergoing a tendon transfer during the study period or who have had a tendon transfer in the past.

Trial design

70 participants in 1 patient group

Surgery

Description:

Surgery/ Occupational Therapy

Treatment:

Procedure: Surgery/Occupational Therapy