protocolSection identificationModule nctId: NCT06288763, orgStudyIdInfo id: SC220192, briefTitle: Nerve Transfer to Improve Function in High Level Tetraplegia, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-05, primaryCompletionDateStruct date: 2028-03-01, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Washington University School of Medicine, class: OTHER, collaborators name: University of Michigan, collaborators name: University of Calgary, collaborators name: The Methodist Hospital Research Institute, collaborators name: University of Pennsylvania, collaborators name: University of Utah, collaborators name: Stanford University, collaborators name: University of Miami, collaborators name: Johns Hopkins University, collaborators name: University of Alberta, descriptionModule briefSummary: 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., conditionsModule conditions: Cervical Spinal Cord Injury, conditions: Tetraplegia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, outcomesModule primaryOutcomes measure: Elbow Dynamometry, primaryOutcomes measure: Spinal Cord Independence Measure, primaryOutcomes measure: Motor strength in medical research council grade (MRC), primaryOutcomes measure: Electrodiagnosis (Nerve Conduction Study and Electromyography, secondaryOutcomes measure: Canadian Outcomes Performance Measure (COPM), secondaryOutcomes measure: Capabilities of Upper Extremity Questionnaire (CUE-Q), secondaryOutcomes measure: Modified Ashworth Scale (MAS), secondaryOutcomes measure: Spinal Cord Injury Quality of LIfe Questionnaire, secondaryOutcomes measure: International SCI Pain Basic Dataset (ISCIPBDS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Stanford University, status: NOT_YET_RECRUITING, city: Stanford, state: California, zip: 94305, country: United States, contacts name: Adrian Valladarez, role: CONTACT, phone: 650-381-4257, email: adrian98@stanford.edu, contacts name: Anthony Bet, role: CONTACT, phone: 650-683-5823, email: abet0915@stanford.edu, contacts name: Thomas J Wilson, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.42411, lon: -122.16608, locations facility: University of Miami, status: RECRUITING, city: Miami, state: Florida, zip: 33136, country: United States, contacts name: George Jimsheleishvili, MD, role: CONTACT, phone: 305-243-4781, email: gxi150@med.miami.edu, contacts name: Patricia Graham, role: CONTACT, phone: 305-243-5119, email: pgraham1@med.miami.edu, contacts name: Stephen S Burks, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Allan Levi, MD, role: SUB_INVESTIGATOR, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Johns Hopkins University, status: NOT_YET_RECRUITING, city: Baltimore, state: Maryland, zip: 21287, country: United States, contacts name: Aston King, role: CONTACT, phone: 667-306-8862, email: aking64@jhu.edu, contacts name: Bronwyn Slobogean, role: CONTACT, email: bslobog1@jhmi.edu, contacts name: Sami Tuffaha, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Allan Belzberg, MD, role: SUB_INVESTIGATOR, geoPoint lat: 39.29038, lon: -76.61219, locations facility: University of Michigan, status: RECRUITING, city: Ann Arbor, state: Michigan, zip: 48109, country: United States, contacts name: Savannah Solomon, role: CONTACT, phone: 734-936-7010, email: ssavanna@med.umich.edu, contacts name: Yamaan Saadeh, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.27756, lon: -83.74088, locations facility: Washington University in St. Louis, status: RECRUITING, city: Saint Louis, state: Missouri, zip: 63110, country: United States, contacts name: Linda Koester, role: CONTACT, phone: 314-362-7368, email: koesterl@wustl.edu, contacts name: Wilson Z. Ray, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.62727, lon: -90.19789, locations facility: University of Pennsylvania, status: RECRUITING, city: Philadelphia, state: Pennsylvania, zip: 19104, country: United States, contacts name: Lora Assi, role: CONTACT, phone: 267-254-4745, email: NCRDNeuroICU@uphs.upenn.edu, contacts name: Leah Coghlan, role: CONTACT, phone: 215-341-5864, email: NCRDNeuroICU@uphs.upenn.edu, contacts name: Eric Zager, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.95233, lon: -75.16379, locations facility: Houston Methodist, status: RECRUITING, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Amber Behne, role: CONTACT, phone: 346-238-6424, email: abehne@houstonmethodist.org, contacts name: Sergio Ibarra Cortez, role: CONTACT, phone: 346-238-2494, email: shibarracortez@houstonmethodist.org, contacts name: Amir Faraji, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, locations facility: University of Utah, status: NOT_YET_RECRUITING, city: Salt Lake City, state: Utah, zip: 84132, country: United States, contacts name: Kirstianna Lombardi, role: CONTACT, phone: 801-585-9821, email: kirstianna.lombardi@utah.edu, contacts name: Douglas Gibula, role: CONTACT, email: douglas.gibula@hsc.utah.edu, contacts name: Mark Mahan, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.76078, lon: -111.89105, locations facility: University of Calgary - Alberta Health Services, status: NOT_YET_RECRUITING, city: Calgary, state: Alberta, zip: T2N 2T9, country: Canada, contacts name: Ish Bains, role: CONTACT, phone: 403-944-4334, email: ish.bains@albertahealthservices.ca, contacts name: Rajiv Midha, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.05011, lon: -114.08529, locations facility: University of Alberta, status: NOT_YET_RECRUITING, city: Edmonton, state: Alberta, zip: T6G 2E1, country: Canada, contacts name: Mith Rajshekar, PhD, role: CONTACT, email: rajsheka@ualberta.ca, contacts name: Andrew Jack, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 53.55014, lon: -113.46871, hasResults: False