[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100536556":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":45,"locations":55,"responsibleParty":93,"collaborators":96,"id":102,"slug":103,"hasResults":104,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":26,"eligibilityCriteria":108,"healthyVolunteers":104,"sex":109,"minAge":110,"maxAge":111,"enrollmentInfo":112,"targetDuration":26,"studyType":115,"phases":116,"briefSummary":118,"conditions":119,"keywords":121,"overallStatus":58,"whyStopped":26,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":140},{"fullName":5,"class":6},"The University of Texas at Dallas","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Immediate VNS Group","ACTIVE_COMPARATOR","The participants in this arm will be implanted with the device and will receive active VNS stimulations in phase 1 as well as phase 2 of the study.",[13],"Device: Active VNS stimulation",{"label":15,"type":16,"description":17,"interventionNames":18},"Delayed VNS Group","SHAM_COMPARATOR","The participants in this arm will be implanted with the device but will receive sham VNS stimulations in phase 1 of the study and active VNS in phase 2 of the study.",[19],"Device: Sham VNS stimulation",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Active VNS stimulation","The subjects in this group will be implanted with the ReStore device and receive active Vagus nerve stimulation (VNS) in phase 1",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Sham VNS stimulation","The subjects in this group will be implanted with the ReStore device and receive sham Vagus nerve stimulation (VNS) in phase 1",[15],[32,35,37,40,43],{"name":33,"affiliation":5,"role":34},"Jane Wigginton, MD","PRINCIPAL_INVESTIGATOR",{"name":36,"affiliation":5,"role":34},"Robert Rennaker, PhD",{"name":38,"affiliation":39,"role":34},"Jasper Smits, PhD","The University of Texas at Austin",{"name":41,"affiliation":42,"role":34},"Michael Foreman, MD","Baylor Scott and White Health",{"name":44,"affiliation":5,"role":34},"Michael Kilgard, PhD",[46,51],{"name":47,"role":48,"phone":49,"phoneExt":26,"email":50},"Amy Porter","CONTACT","972-883-7256","alp160730@utdallas.edu",{"name":52,"role":48,"phone":53,"phoneExt":26,"email":54},"Katharine Dlouhy","972-883-7231","katharine.dlouhy@utdallas.edu",[56,70,82],{"facility":57,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":26},"The University of Texas Health Austin Ambulatory Surgery Center","RECRUITING","Austin","Texas","78712","United States","US",{"type":65,"coordinates":66},"Point",[67,68],-97.74306,30.26715,{"lat":68,"lon":67},{"facility":71,"status":58,"city":72,"state":60,"zip":73,"country":62,"countryCode":63,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Baylor University Medical Center","Dallas","75246",{"type":65,"coordinates":75},[76,77],-96.80667,32.78306,{"lat":77,"lon":76},[80],{"name":26,"role":48,"phone":81,"phoneExt":26,"email":26},"(214) 865-2416",{"facility":83,"status":58,"city":84,"state":60,"zip":85,"country":62,"countryCode":63,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Texas Biomedical Device Center","Richardson","75080",{"type":65,"coordinates":87},[88,89],-96.72972,32.94818,{"lat":89,"lon":88},[92],{"name":47,"role":48,"phone":49,"phoneExt":26,"email":26},{"type":34,"investigatorFullName":94,"investigatorTitle":95,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Dr. Seth Hays","Professor",[97,100],{"name":98,"class":99},"Congressionally Directed Medical Research Programs","FED",{"name":101,"class":6},"The University of Texas Health Science Center at San Antonio","100536556","targeted-plasticity-therapy-for-ptsd-100536556",false,"NCT06266364","Targeted Plasticity Therapy for PTSD","Targeted Plasticity Therapy for the Treatment of Post-Traumatic Stress Disorder","Inclusion Criteria:\n\n1. Diagnosis of chronic PTSD for at least 3 months based on DSM-5 criteria\n2. In the medical opinion of the Principal Investigator (PI), failed at least one adequate course of first-line PTSD treatment per American Psychological Association (APA) guidelines\n3. PCL-5 score greater than 33\n4. Age 22-79 years\n5. Appropriate surgical candidate for VNS device implantation\n6. Willing and able to comply with study protocol\n7. Able to provide informed consent.\n\nExclusion Criteria:\n\n1. Currently undergoing prolonged exposure therapy elsewhere\n2. Concurrent participation in another interventional clinical trial\n3. Prior injury to vagus nerve\n4. Prior or current treatment with vagus nerve stimulation\n5. Psychiatric disorders and\u002For cognitive impairments that would interfere with study participation, as assessed by medical evaluation\n6. Moderate-High Risk of Suicide according to Columbia - Suicide Severity Rating Scale (C-SSRS) Screen Version\n7. Persons with a current or past: (a) medical (psychiatric, non-psychiatric) condition, disease, disorder, injury, or disability or (b) non-medical situation or circumstance that, in the opinion of the principal investigator, study participation:\n\n   * may pose a significant or undue risk to the person,\n   * make it unlikely the person will complete all the study requirements per protocol, or\n   * may adversely impact the integrity of the data or the validity of the study results\n8. Persons with a neck circumference larger than 18.5 inches\n9. Females of childbearing potential who are either pregnant or planning to become pregnant and who are not using, or will not agree to use medically acceptable birth control methods\n10. Non-English speaking\n11. As determined by the principal investigator, is under current incarceration or legal detention","ALL","22 Years","79 Years",{"count":113,"type":114},20,"ESTIMATED","INTERVENTIONAL",[117],"NA","Objectives of this study are to provide continued safety assessment for the ReStore system, and to gain further estimates of the effect size of Vagus Nerve Stimulation (VNS) therapy with Prolonged Exposure Therapy (PE) compared to PE with placebo (sham) stimulation in participants with posttraumatic stress disorder (PTSD)",[120],"PTSD, Post Traumatic Stress Disorder",[122,123,124,125,126,127,128,129,130],"PTSD, Post-Traumatic Stress Disorder","VNS, Vagus Nerve Stimulation","TPT, Targeted Plasticity Therapy","ReStore System","PE, Prolonged Exposure Therapy","Trauma and Stressor Related Disorders","Mental Disorders","Stress Disorders, Traumatic","Stress Disorders, Post-Traumatic","2026-06-04",{"date":133,"type":134},"2026-06-08","ACTUAL",{"date":136,"type":134},"2024-12-30",{"date":138,"type":114},"2028-06",{"name":5,"class":6},3]