Clinical trial NCT06288763: Nerve Transfer to Improve Function in High Level Tetraplegia
Official title: Nerve Transfer to Restore Upper Limb Function and Quality of Life in High Tetraplegia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cervical Spinal Cord Injury
Tetraplegia
Keywords: Spinal Cord Injury
Cervical spinal cord injury
Nerve Transfer Surgery
High Cervical Spinal Cord Injury
Cervical SCI
Tetraplegia
Quadriplegia
Nerve transfer
Spinal Accessory Nerve
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: University of Michigan
name: University of Calgary
name: The Methodist Hospital Research Institute
name: University of Pennsylvania
name: University of Utah
name: Stanford University
name: University of Miami
name: Johns Hopkins University
name: University of Alberta
First posted: 2024-03-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with high-level SCI injury (C1-C4) with complete lack of upper extremity function. Occurrence of injury should be greater than 6 months but fewer than 60 months

Brief summary: 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.

Detailed 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)

Eligibility criteria: 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

Primary outcomes:
measure: Elbow Dynamometry
timeFrame: 36-48 months post-surgery
measure: Spinal Cord Independence Measure
timeFrame: 36-48 months post-surgery
measure: Motor strength in medical research council grade (MRC)
timeFrame: 36-48 months post-surgery
measure: Electrodiagnosis (Nerve Conduction Study and Electromyography
timeFrame: 36-48 months post-surgery
Secondary outcomes:
measure: Canadian Outcomes Performance Measure (COPM)
timeFrame: 36-48 Months post-surgery
measure: Capabilities of Upper Extremity Questionnaire (CUE-Q)
timeFrame: 36-48 Months post-surgery
measure: Modified Ashworth Scale (MAS)
timeFrame: 36-48 Months post-surgery
measure: Spinal Cord Injury Quality of LIfe Questionnaire
timeFrame: 36-48 Months post-surgery
measure: International SCI Pain Basic Dataset (ISCIPBDS)
timeFrame: 36-48 Months post-surgery
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 in St. Louis
state: Missouri
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Houston
country: United States
facility: Houston Methodist
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Calgary
country: Canada
facility: University of Calgary - Alberta Health Services
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: