[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100396084":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":28,"centralContacts":33,"locations":43,"responsibleParty":60,"collaborators":62,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":24,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":45,"whyStopped":24,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"VA Office of Research and Development","FED",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"nVNS","EXPERIMENTAL","non invasive vagal nerve stimulation",[13],"Device: nVNS",{"label":15,"type":16,"description":17,"interventionNames":18},"sham","SHAM_COMPARATOR","sham stimulation",[19],"Device: sham stimulation",[21,25],{"type":22,"name":17,"description":11,"armGroupLabels":23,"otherNames":24},"DEVICE",[15],null,{"type":22,"name":9,"description":26,"armGroupLabels":27,"otherNames":24},"active vns stimulation",[9],[29],{"name":30,"affiliation":31,"role":32},"Doug J Bremner, MD","Atlanta VA Medical and Rehab Center, Decatur, GA","PRINCIPAL_INVESTIGATOR",[34,38],{"name":30,"role":35,"phone":36,"phoneExt":24,"email":37},"CONTACT","(404) 712-9569","James.Bremner@va.gov",{"name":39,"role":35,"phone":40,"phoneExt":41,"email":42},"Anna Woodbury, MD","(404) 321-6111","6939","Anna.Woodbury@va.gov",[44],{"facility":31,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"RECRUITING","Decatur","Georgia","30033-4004","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-84.29631,33.77483,{"lat":55,"lon":54},[58,59],{"name":30,"role":35,"phone":36,"phoneExt":24,"email":37},{"name":30,"role":32,"phone":24,"phoneExt":24,"email":24},{"type":61,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[63],{"name":64,"class":6},"Atlanta VA Medical Center","100396084","vagal-nerve-stimulation-in-mtbi-100396084",false,"NCT04437498","Vagal Nerve Stimulation in mTBI","Non-Invasive Vagal Nerve Stimulation in Veterans With Mild Traumatic Brain Injury (mTBI)","VNS mTBI","Inclusion Criteria:\n\n* Veterans with mTBI and PTSD\n\nExclusion Criteria:\n\n* amnesia for the inciting event lasted longer than 24 hours\n* Glasgow Coma Scale Score after 30 minutes was less than 13\n* loss of consciousness more than 30 minutes\n* positive pregnancy test\n* meningitis or other neurological disorder other than mTBI\n* alcohol or substance abuse use disorder based on the SCID within the past 12 months\n* current or lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, anorexia nervosa or bulimia, based on the SCID\n* active suicidal ideation based on criteria outlined below\n* a history of serious medical or neurological illness, such as cardiovascular, gastrointestinal, hepatic, renal, neurologic or other systemic illness\n* active neuroleptic, opiate, or benzodiazepine treatment\n* structural abnormality on brain MRI or CT","ALL","18 Years","55 Years",{"count":77,"type":78},100,"ESTIMATED","INTERVENTIONAL",[81],"NA","Mild traumatic brain injury (mTBI) and posttraumatic stress disorder (PTSD) are important conditions for the Veterans Administration (VA) that frequently occur together in combat Veterans from the conflicts in Afghanistan and Iraq. In many Veterans these become chronic, raising the risk the burden of neurotrauma can worsen over time. This study will examine a new intervention called non-invasive Vagal Nerve Stimulation (nVNS) and its effects on memory and symptoms of PTSD and mTBI as well as brain and physiology in Veterans with mTBI and PTSD.",[84,85],"PTSD","mTBI",[87,88,89,90,91,92],"vagus nerve","stress disorders, posttraumatic","traumatic brain injury","memory","hippocampus","emission tomography","2026-07-16",{"date":95,"type":96},"2026-07-20","ACTUAL",{"date":98,"type":96},"2021-02-25",{"date":100,"type":78},"2026-12-10",{"name":5,"class":6},1]