[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571706":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":31,"locations":37,"responsibleParty":73,"collaborators":75,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":80,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":25,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":40,"whyStopped":25,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Baylor College of Medicine","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"taVNS active stimulation","ACTIVE_COMPARATOR","Participants will receive transcutaneous auricular vagus nerve stimulation (taVNS) using electrodes placed on the left ear. A low-level electrical current will be delivered to stimulate the vagus nerve. This stimulation is designed to activate brain areas involved in attention and memory.",[13,14],"Other: Transcutaneous vagus nerve stimulation for attention in veterans with TBI","Device: Soterix Medical Vagus Nerve Stimulation mini-CT",{"label":16,"type":17,"description":18,"interventionNames":19},"Sham (Placebo) taVNS","SHAM_COMPARATOR","Participants will undergo sham stimulation, where electrodes are placed on the left ear to mimic the experience of active taVNS. However, no electrical current will be delivered to the vagus nerve. This sham condition enables a direct comparison with active taVNS, ensuring that any observed changes in working memory and attention can be attributed to the taVNS intervention.",[13,14],[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Transcutaneous vagus nerve stimulation for attention in veterans with TBI","taVNS does not require surgery or medication, offering a safe and accessible treatment option. Each participant undergoes both an active taVNS session and a sham (placebo) session. Sham stimulation mimics the sensory experience of taVNS but does not deliver electrical currents to the vagus nerve, ensuring blinding and providing robust comparisons. The study is completed in a single visit lasting 2.5 to 3 hours, minimizing participant burden.",[16,9],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":25},"DEVICE","Soterix Medical Vagus Nerve Stimulation mini-CT","Soterix Medical min-CT VNS device is used for non-invasive stimulation procedures and trials. It has blinding features such as single-blind for this study in which patients will either receive active or shame taVNS.",[16,9],[32],{"name":33,"role":34,"phone":35,"phoneExt":25,"email":36},"Lane Witkowski Research Coordinator","CONTACT","206-419-1261","Lane.Witkowski@va.gov",[38,62],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Michael E. DeBakey VA Medical Center","RECRUITING","Houston","Texas","77030","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-95.36327,29.76328,{"lat":50,"lon":49},[53,58,61],{"name":54,"role":34,"phone":55,"phoneExt":56,"email":57},"Ricardo Jorge, MD","(713) 791-1414","226175","ricardo.jorge@bcm.edu",{"name":59,"role":60,"phone":25,"phoneExt":25,"email":25},"Principal Investigator","PRINCIPAL_INVESTIGATOR",{"name":54,"role":60,"phone":25,"phoneExt":25,"email":25},{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":63,"geoPoint":65,"contacts":66},{"type":47,"coordinates":64},[49,50],{"lat":50,"lon":49},[67,70],{"name":68,"role":34,"phone":35,"phoneExt":25,"email":69},"Lane Witkowski","lane.witkowski@bcm.edu",{"name":71,"role":34,"phone":25,"phoneExt":25,"email":72},"Audri Villalon","audriv@bcm.edu",{"type":60,"investigatorFullName":54,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Professor",[76],{"name":39,"class":77},"FED","100571706","transcutaneous-vagus-nerve-stimulation-for-attention-and-memory-100571706",false,"NCT06723743","Transcutaneous Vagus Nerve Stimulation for Attention and Memory","Transcutaneous Auricular Vagus Nerve Stimulation Effects on Attention and Working Memory: A Pilot Study","taVNS","Inclusion Criteria:\n\n* Ages 25-64\n* Right-handedness\n* Veterans with a history of deployment to Operation Iraqi Freedom (OIF), Operation Enduring Freedom (OEF), Operation New Dawn (OND) or other post 9\u002F11 war on terrorism\n* History of PTSD and\u002For depression\n* Military related mild traumatic brain injury\n* If taking psychotropic medication, demonstrate stability for 3 months\n* If taking stimulants, washout period of 12 hours\n\nExclusion Criteria:\n\n* History of neurological, cardiovascular, or pulmonary disease\n* Cardiac arrhythmia (all types)\n* Active suicidal ideation\n* Visible wounds on skin of the left ear\n* Medical implants such as cardiac defibrillators, pacemakers, or deep brain stimulators\n* Pregnancy\n* Completed taVNS in the past 4 weeks\n* Current substance use disorder (exception: mild cannabis use disorder allowed)\n* Current moderate or severe alcohol use disorder\n* Major cognitive disorder","ALL","25 Years","64 Years",{"count":90,"type":91},30,"ESTIMATED","INTERVENTIONAL",[94],"NA","This clinical trial aims to evaluate whether transcutaneous auricular vagus nerve stimulation (taVNS), a non-invasive brain stimulation method, can improve attention and memory in veterans with traumatic brain injury (TBI) and depression and\u002For posttraumatic stress disorder (PTSD). The study seeks to answer two main questions:\n\n1. Can active taVNS improve attention and memory compared to sham (placebo) stimulation?\n2. Does taVNS affect heart rate variability (HRV)?\n\ntaVNS delivers a gentle electrical current to the vagus nerve through electrodes placed on the ear, targeting brain areas involved in attention and memory without requiring surgery.\n\nThis study uses a crossover design, meaning all participants will experience two sessions: one with active taVNS and one with sham stimulation. The sham session feels similar but does not deliver actual stimulation, allowing researchers to compare the two and understand taVNS's effects on the brain.\n\nIn a single visit, participants will:\n\n* Complete eligibility screening (questionnaires and vital signs).\n* Undergo two sessions (one active and one sham), randomly assigned.\n* Perform attention tasks before and after each session.\n* Have their heart rate monitored during the sessions.\n\nThe findings will help determine whether taVNS could be an effective treatment for improving attention and memory in veterans with TBI.",[97],"Traumatic Brain Injury (TBI) Patients",[99,100,101,102,103],"vagus nerve stimulation","attention","brain stimulation","PTSD","depression","2026-05-05",{"date":106,"type":107},"2026-05-07","ACTUAL",{"date":109,"type":91},"2026-08",{"date":111,"type":91},"2027-08",{"name":5,"class":6},2]