Nerve Transfer After Spinal Cord Injury- Multi-center

Last updated: October 23, 2024
Sponsor: Washington University School of Medicine
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Spinal Cord Injuries

Limb Spasticity

Treatment

Surgery/Occupational Therapy

Clinical Study ID

NCT04023591
SC180063
  • Ages 18-65
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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.

Study Design

Total Participants: 70
Treatment Group(s): 1
Primary Treatment: Surgery/Occupational Therapy
Phase:
Study Start date:
April 13, 2020
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Alberta Health Services - Foothills Medical Center

    Calgary, Alberta T2N 2T9
    Canada

    Site Not Available

  • University of Alberta

    Edmonton, Alberta T6G 2E1
    Canada

    Site Not Available

  • Stanford University

    Stanford, California 94305
    United States

    Site Not Available

  • University of Miami

    Miami, Florida 33136
    United States

    Site Not Available

  • Johns Hopkins University

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Washington University

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Duke University

    Durham, North Carolina 27710
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Houston Methodist

    Houston, Texas 77030
    United States

    Site Not Available

  • The University of Texas Houston Health Science Center

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Utah

    Salt Lake City, Utah 84132
    United States

    Site Not Available

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