[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06288763":3,"trial-entities:NCT06288763":287,"trial-summary:NCT06288763":290},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":30,"primary_purpose":31,"phases":32,"enrollment_info":33,"interventions":36,"primary_outcomes":37,"secondary_outcomes":51,"sex":68,"minimum_age":69,"maximum_age":70,"healthy_volunteers":15,"eligibility_criteria":71,"std_ages":90,"locations":93,"central_contacts":276,"overall_officials":280,"references":282,"see_also_links":283},"NCT06288763","CDMRP-eBRAP-SC220192","Nerve Transfer to Improve Function in High Level Tetraplegia","Nerve Transfer to Restore Upper Limb Function and Quality of Life in High Tetraplegia","RECRUITING","2028-12-31","2026-03","2026-03-11","2024-02-05","Washington University School of Medicine","OTHER",false,"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.\n\nParticipants will:\n\n* undergo standard of care pre- and post-op testing and study exams\n* complete pre- and post-questionnaires\n* undergo standard of care nerve transfer surgeries\n* follow-up with surgeon at 6\u002F12\u002F18\u002F24\u002F36 and potentially at 48 months\n* attend therapy at local therapist for up to 2 years postop.","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\u002Fprocedure which improves the upper extremity function in patients with high tetraplegia.\n\nOne 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.\n\nThe two objectives of this study are:\n\n* Determine if SAN nerve transfer surgery can improve the reinnervation of bicep or tricep muscles in high tetraplegia patients.\n* Determine if SAN nerve transfer surgery can reanimate upper arm function and improve functional independence in patients with high tetraplegia.\n\nStudy Activities (including standard of care (SOC))\n\n* Electrodiagnosis pre-op (SOC)\n* Upper extremity maximum muscle testing (SOC)\n* Questionnaires (SOC and study-related (SR))\n* Exams by a study therapist (SR)\n* Neurological exam - ISNCSCI - (SOC)\n* Nerve Transfer Surgery to be determined by surgeon (SOC)\n* Follow-up visits with surgeon at 6\u002F12\u002F18\u002F24\u002F36 and potentially 48 months\n* post-op electrodiagnostic testing (SR)\n* post-op upper extremity maximum muscle testing (SOC)\n* post-op questionnaires\n* post-op therapy exams (SR)",[19,20],"Cervical Spinal Cord Injury","Tetraplegia",[22,23,24,25,26,20,27,28,29],"Spinal Cord Injury","Cervical spinal cord injury","Nerve Transfer Surgery","High Cervical Spinal Cord Injury","Cervical SCI","Quadriplegia","Nerve transfer","Spinal Accessory Nerve","OBSERVATIONAL",null,[],{"count":34,"type":35},30,"ESTIMATED",[],[38,42,45,48],{"measure":39,"description":40,"timeFrame":41},"Elbow Dynamometry","Change from baseline to 36-48 months post-surgery. Elbow dynamometer measures muscle strength using a handheld portable dynamometer","36-48 months post-surgery",{"measure":43,"description":44,"timeFrame":41},"Spinal Cord Independence Measure","Change from baseline to 36-48 months post-surgery. SCIM addresses three specific areas of function in patients with SCI, 1) Self-care (feeding, grooming, bathing, and dressing), 2) respiration and sphincter management, and 3) patient's mobility abilities (transfers from bed and indoors\u002Foutdoors). SCIM guide clinicians in determining treatment goals\u002Fobjectives for SCI patients helping therapists assess measurable outcomes in their functional independence. Scores range from 0-100 with a higher score representing better function.",{"measure":46,"description":47,"timeFrame":41},"Motor strength in medical research council grade (MRC)","Change in baseline to 36-48 Months post-surgery. The manual muscle testing is a reliable measure of motor strength when assessed by a trained examiner. Scores range from 0-5, with the highest number representing a better score.",{"measure":49,"description":50,"timeFrame":41},"Electrodiagnosis (Nerve Conduction Study and Electromyography","Change in baseline to 36-48 Months post-surgery. NCS\u002FEMG evaluate neuromuscular health and inform the integrity of lower motor neurons.",[52,56,59,62,65],{"measure":53,"description":54,"timeFrame":55},"Canadian Outcomes Performance Measure (COPM)","Change from baseline to 36-48 months post-surgery. COPM is a validated outcome measure for SCI patients focusing on occupational performance in all areas of life. Scores range from 5-50 for performance and satisfaction. The higher scores reflect better performance and satisfaction.","36-48 Months post-surgery",{"measure":57,"description":58,"timeFrame":55},"Capabilities of Upper Extremity Questionnaire (CUE-Q)","Change from baseline to 36-48 months post-surgery. CUE-Q detects changes in upper extremity function. Scores range from 32-224 with higher scores reflecting better function.",{"measure":60,"description":61,"timeFrame":55},"Modified Ashworth Scale (MAS)","Change from baseline to 36-48 months post-surgery. MAS is a reliable measure for rating spasticity in SCI. Scores range from 0-32 with higher scores reflecting better function.",{"measure":63,"description":64,"timeFrame":55},"Spinal Cord Injury Quality of LIfe Questionnaire","Change from baseline to 36-48 months post-surgery. SCI-QOL is designed to measure subjective quality of life in terms of satisfaction and importance. Range of scores is 0 to 30 with the higher scores reflecting a better quality of life..",{"measure":66,"description":67,"timeFrame":55},"International SCI Pain Basic Dataset (ISCIPBDS)","Change from baseline to 36-48 months post-surgery. ISCIPBDS correctly classifies pain, determines its intensity and broad impact on daily activities. Lower scores reflect less pain\u002Fless interference in daily life.","ALL","18 Years","80 Years",{"inclusion":72,"exclusion":80,"raw_text":89},[73,74,75,76,77,78,79],"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\u002F5 donor strength","Mentally and physically willing and able to comply with evaluations",[81,82,83,84,85,86,87,88],"Active infection at the operative site or systemic infection","Any return or ongoing recovery of distal motor function","Significant joint contractures and\u002For 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","Inclusion Criteria:\n\n* 18-80 years of age\n* High cervical SCI (motor level C1-C4)\n* Motor complete SCI AIS grade A-B\n* Plateaued spontaneous recovery for at least 6 months of non-operative therapy\n* SCI greater than 6 months and fewer than 60 months since injury\n* At least MRC 4\u002F5 donor strength\n* Mentally and physically willing and able to comply with evaluations\n\nExclusion Criteria:\n\n* Active infection at the operative site or systemic infection\n* Any return or ongoing recovery of distal motor function\n* Significant joint contractures and\u002For limitations in passive range of motion in the arm\n* Mentally or physically compromised making it impossible to complete study activities\n* Immunologically suppressed\n* Currently undergoing long-term steroid therapy\n* Active malignancy\n* Pregnancy",[91,92],"ADULT","OLDER_ADULT",[94,112,134,154,169,184,202,222,241,259],{"facility":95,"status":8,"city":96,"state":97,"zip":98,"country":99,"contacts":100,"geoPoint":109},"Stanford University","Stanford","California","94305","United States",[101,106],{"name":102,"role":103,"phone":104,"email":105},"Anthony Bet","CONTACT","650-683-5823","abet0915@stanford.edu",{"name":107,"role":108},"Thomas J Wilson, MD","PRINCIPAL_INVESTIGATOR",{"lat":110,"lon":111},37.42411,-122.16608,{"facility":113,"status":8,"city":114,"state":115,"zip":116,"country":99,"contacts":117,"geoPoint":131},"University of Miami","Miami","Florida","33136",[118,122,126,128],{"name":119,"role":103,"phone":120,"email":121},"George Jimsheleishvili, MD","305-243-4781","gxi150@med.miami.edu",{"name":123,"role":103,"phone":124,"email":125},"Patricia Graham","305-243-5119","pgraham1@med.miami.edu",{"name":127,"role":108},"Stephen S Burks, MD",{"name":129,"role":130},"Allan Levi, MD","SUB_INVESTIGATOR",{"lat":132,"lon":133},25.77427,-80.19366,{"facility":135,"status":8,"city":136,"state":137,"zip":138,"country":99,"contacts":139,"geoPoint":151},"Johns Hopkins University","Baltimore","Maryland","21287",[140,144,147,149],{"name":141,"role":103,"phone":142,"email":143},"Chava Roberts","667-306-8862","crober83@jh.edu",{"name":145,"role":103,"email":146},"Ala Elhelali","aelhela1@jhmi.edu",{"name":148,"role":108},"Sami Tuffaha, MD",{"name":150,"role":130},"Allan Belzberg, MD",{"lat":152,"lon":153},39.29038,-76.61219,{"facility":155,"status":8,"city":156,"state":157,"zip":158,"country":99,"contacts":159,"geoPoint":166},"University of Michigan","Ann Arbor","Michigan","48109",[160,164],{"name":161,"role":103,"phone":162,"email":163},"Savannah Solomon","734-936-7010","ssavanna@med.umich.edu",{"name":165,"role":108},"Yamaan Saadeh, MD",{"lat":167,"lon":168},42.27756,-83.74088,{"facility":170,"status":8,"city":171,"state":172,"zip":173,"country":99,"contacts":174,"geoPoint":181},"Washington University in St. Louis","St Louis","Missouri","63110",[175,179],{"name":176,"role":103,"phone":177,"email":178},"Linda Koester","13143627368","koesterl@wustl.edu",{"name":180,"role":108},"Wilson Z. Ray, MD",{"lat":182,"lon":183},38.62727,-90.19789,{"facility":185,"status":8,"city":186,"state":187,"zip":188,"country":99,"contacts":189,"geoPoint":199},"Wake Forest Medical Center","Winston-Salem","North Carolina","27157",[190,194,197],{"name":191,"role":103,"phone":192,"email":193},"Wendy Jenkins","336-716-3842","wendy.jenkins@advocatehealth.org",{"name":195,"role":103,"email":196},"Kim Hawley","kimberly.hawley@advocatehealth.org",{"name":198,"role":108},"Christopher Dibble, MD",{"lat":200,"lon":201},36.09986,-80.24422,{"facility":203,"status":8,"city":204,"state":205,"zip":206,"country":99,"contacts":207,"geoPoint":219},"University of Pennsylvania","Philadelphia","Pennsylvania","19104",[208,212,215,217],{"name":209,"role":103,"phone":210,"email":211},"Leah Coghlan","215-341-5864","leah.coghlan@pennmedicine.upenn.edu",{"name":213,"role":103,"email":214},"Gabrielle Dupre","gabrielle.dupre@pennmedicine.upenn.edu",{"name":216,"role":108},"Eric Zager, MD",{"name":218,"role":130},"Zarina Ali, MD",{"lat":220,"lon":221},39.95238,-75.16362,{"facility":223,"status":8,"city":224,"state":225,"zip":226,"country":99,"contacts":227,"geoPoint":238},"Houston Methodist","Houston","Texas","77030",[228,232,236],{"name":229,"role":103,"phone":230,"email":231},"Amber Behne","346-238-6424","abehne@houstonmethodist.org",{"name":233,"role":103,"phone":234,"email":235},"Sergio Ibarra Cortez","346-238-2494","shibarracortez@houstonmethodist.org",{"name":237,"role":108},"Amir Faraji, MD",{"lat":239,"lon":240},29.76328,-95.36327,{"facility":242,"status":8,"city":243,"state":244,"zip":245,"country":99,"contacts":246,"geoPoint":256},"University of Utah","Salt Lake City","Utah","84132",[247,251,254],{"name":248,"role":103,"phone":249,"email":250},"Kirstianna Lombardi","801-585-9821","kirstianna.lombardi@utah.edu",{"name":252,"role":103,"email":253},"Douglas Gibula","douglas.gibula@hsc.utah.edu",{"name":255,"role":108},"Mark Mahan, MD",{"lat":257,"lon":258},40.76078,-111.89105,{"facility":260,"status":261,"city":262,"state":263,"zip":264,"country":265,"contacts":266,"geoPoint":273},"University of Alberta","NOT_YET_RECRUITING","Edmonton","Alberta","T6G-2E1","Canada",[267,271],{"name":268,"role":103,"phone":269,"email":270},"Mithun Rajshekar, PhD","780-248-1896","rajsheka@ulaberta.ca",{"name":272,"role":108},"Andrew Jack, MD",{"lat":274,"lon":275},53.55014,-113.46871,[277],{"name":278,"role":103,"phone":279,"email":178},"Linda Koester, BS","314-362-7368",[281],{"name":180,"affiliation":13,"role":108},[],[284],{"label":285,"url":286},"Washington University Neurosurgery Website","http:\u002F\u002Fwww.neurosurgery.wustl.edu",{"nct_id":4,"conditions":288,"biomarkers":289},[23,27],[],{"nct_id":4,"found":291,"summary":292,"prompt_version":302},true,{"design":293,"status":294,"heading":295,"summary":296,"follow_up":297,"word_count":298,"commitments":299,"compensation":300,"drugs_mentioned":301},"This is an observational study, meaning researchers will watch and record outcomes without assigning specific treatments. It plans to enroll 30 participants.","completed","Nerve Transfer for High-Level Tetraplegia","This observational study is looking at whether nerve transfer surgeries can improve arm and hand function and quality of life for people with a high-level cervical spinal cord injury (tetraplegia). Specifically, it aims to see if transferring the spinal accessory nerve (SAN) can help reanimate the bicep or tricep muscles and improve independence. You might be able to join if you are 18-80 years old, have a high cervical spinal cord injury (C1-C4 motor level) that is motor complete (AIS grade A-B), and your recovery has plateaued for at least 6 months. Your injury must be between 6 and 60 months old, and you need to have good strength in the donor nerve. The study will measure improvements in elbow strength and independence after surgery. The current status of this study is unclear.","Participants will be followed for up to 48 months after surgery to assess outcomes.",133,"You would undergo standard pre- and post-operative tests, complete questionnaires, have nerve transfer surgery, and attend follow-up visits with your surgeon for up to 48 months. You would also attend therapy at a local therapist for up to 2 years after surgery.","Not stated in the trial record.",[],"v2"]