[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636163":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":36,"responsibleParty":53,"collaborators":30,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":30,"studyType":70,"phases":71,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":82,"whyStopped":30,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"University of Alabama at Birmingham","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"taVNS application","EXPERIMENTAL","This is a single arm study with two Phases.\n\nIn Phase 1 taVNS will be applied bilaterally for a brief period while the individual is in inpatient rehabilitation\n\nIn Phase 2 taVNS will be applied for a brief period immediately before each mobility therapy session while the period is in inpatient rehabilitation. The mobility therapy sessions are routine care. Frequency and intensity of these sessions are determined by the therapists.\n\nAll individuals must complete Phase 1 before starting Phase 2. Not all individuals who complete Phase 1 will be eligible for Phase 2. Please see eligibility criteria for more details.",[13],"Device: Transauricular vagus nerve stimulation",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Transauricular vagus nerve stimulation","bilateral transauricular vagal nerve stimulation",[9],[21],"taVNS",[23],{"name":24,"affiliation":5,"role":25},"Rachel E Cowan, PhD","PRINCIPAL_INVESTIGATOR",[27,32],{"name":24,"role":28,"phone":29,"phoneExt":30,"email":31},"CONTACT","2059345034",null,"recowan@uabmc.edu",{"name":33,"role":28,"phone":34,"phoneExt":30,"email":35},"Christopher Williamson, MBA","2059343776","cmwilliamson@uabmc.edu",[37],{"facility":5,"status":30,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Birmingham","Alabama","35233","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-86.80249,33.52066,{"lat":47,"lon":46},[50,51],{"name":24,"role":28,"phone":29,"phoneExt":30,"email":31},{"name":52,"role":28,"phone":29,"phoneExt":30,"email":31},"Rachel",{"type":25,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Rachel Cowan","Associate Professor","100636163","phase-1-pilot-testing-of-vagus-nerve-stimulation-for-early-spinal-cord-injury-recovery-100636163",false,"NCT07562113","Pilot Testing of Vagus Nerve Stimulation for Early Spinal Cord Injury Recovery","Pilot Investigation of Transauricular Vagal Nerve Stimulation Safety and Feasibility in Acute Incomplete Spinal Cord Injury Rehabilitation","PIVOTS-Rehab","Inclusion Criteria:\n\n* Phase 1 Age 18 years older SCI (traumatic or non traumatic) undergoing initial inpatient rehabilitation for the SCI Any AIS severity level (A, B, C, D)\n* Phase 2 Completed phase I Participant willing to complete phase II Study physician approves participation in phase II Receives intensive gait training as a part of the care plan\n\nExclusion Criteria:\n\n* Phase 1 Age \\>89 years Pregnant Implanted medical device (e.g. pacemaker, cochlear implant) epilepsy Parkinson's Disease Multiple Sclerosis cerebral shunts documented arrhythmia Ear skin irritation or damage at the electrode contact location intracranial metal implants\n* Phase 2 no exclusion criteria for those who meet inclusion criteria","ALL","18 Years","89 Years",{"count":68,"type":69},50,"ESTIMATED","INTERVENTIONAL",[72,73],"PHASE1","PHASE2","This study looks at a treatment called transcutaneous auricular vagus nerve stimulation, or taVNS. taVNS uses a small device worn on the ear to gently stimulate a nerve. Researchers want to find out if this treatment is safe and well-tolerated for people who recently had a spinal cord injury (SCI).\n\nThis study will also help researchers learn whether taVNS can be safely added to standard mobility therapy, and whether it might help improve mobility.\n\nThis study has two main goals:\n\n1. To find out whether taVNS is safe and comfortable for people with a recent spinal cord injury.\n2. To get information on whether taVNS may help improve mobility when compared to people who completed rehabilitation before this study started.\n\nThis study has two parts.\n\nIn the first part, participants will wear the taVNS device once for a short period of time. During this part investigators will measure how participant's heart rate and blood pressure may change before, during, and after the stimulation. Investigators will also ask about how the stimulation made participants feel.\n\nIn the second part, participants will wear the taVNS device for a short time right before a mobility therapy session. During this part investigators will measure how participants heart rate and blood pressure may change before, during, and after the stimulation and during and after the walking therapy. Investigators will also ask about how the stimulation made participants feel.",[76],"Spinal Cord Injuries (Complete and Incomplete)",[78,79,80,81],"vagus nerve stimulation","spinal cord injuries","Rehabilitation","walking","NOT_YET_RECRUITING","2026-05-20",{"date":85,"type":86},"2026-05-22","ACTUAL",{"date":88,"type":69},"2026-06-01",{"date":90,"type":69},"2027-12-15",{"name":5,"class":6},1]