Clinical trial NCT04023591: Nerve Transfer After Spinal Cord Injury- Multi-center
Official title: Nerve Transfers to Improve Upper Extremity Function and Quality of Life in Tetraplegic Patients
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Tetraplegia
Spinal Cord Injuries
Quadriplegia Flaccid
Keywords: tetraplegia
spinal cord injury
quadriplegia
nerve transfer
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Stanford University
name: University of Pennsylvania
name: University of Michigan
name: University of Calgary
name: University of Utah
name: United States Department of Defense
name: The Methodist Hospital Research Institute
name: University of Miami
name: Johns Hopkins University
name: University of Alberta
First posted: 2019-07-17
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with a traumatic cervical spine injury with little to no use of his/her arms/hands.

Brief 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Manual Motor Testing
timeFrame: 48 months
measure: Handheld Dynamometry
timeFrame: 48 months
Secondary outcomes:
measure: Change in Disabilities of Arm, Shoulder and Hand (DASH) scores
timeFrame: 48 months
measure: Change in Spinal Cord Injury Quality of Life (SCIQOL) scores
timeFrame: 48 months
measure: Rates of Intra-operative and post-operative complications
timeFrame: 48 months
measure: Hand Function, measured by the GRASSP test
timeFrame: 48 months
measure: Changes in the Graded Redefined Assessment of Strength, Sensation and Prehension scores (GRASSP)
timeFrame: 48 months
measure: Neuro Quality of Life - Depression Short Form (NQOL-Dep)
timeFrame: 48 months
measure: Neuro Quality of Life - Upper Extremity Short Form (NQOL-UEF)
timeFrame: 48 Months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Houston
country: United States
facility: Houston Methodist
state: Texas
city: Houston
country: United States
facility: The University of Texas Houston Health Science Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Calgary
country: Canada
facility: Alberta Health Services - Foothills Medical Center
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: Washington University School of Medicine
name: Wilson Z Ray, MD
role: PRINCIPAL_INVESTIGATOR
References: