[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100357341":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":46,"centralContacts":56,"locations":66,"responsibleParty":118,"collaborators":121,"id":129,"slug":130,"hasResults":131,"nctId":132,"briefTitle":133,"officialTitle":133,"acronym":61,"eligibilityCriteria":134,"healthyVolunteers":131,"sex":135,"minAge":136,"maxAge":137,"enrollmentInfo":138,"targetDuration":61,"studyType":141,"phases":142,"briefSummary":144,"conditions":145,"keywords":147,"overallStatus":69,"whyStopped":61,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":165},{"fullName":5,"class":6},"The University of Texas at Dallas","OTHER",[8,15,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Sham rTMS + CPT","SHAM_COMPARATOR","30 minutes of sham repetitive transcranial magnetic stimulation (rTMS) to the right dorsolateral prefrontal cortex (rDLPFC) prior to each Cognitive Processing Therapy (CPT) session",[13,14],"Device: Active rTMS","Behavioral: Cognitive Processing Therapy",{"label":16,"type":17,"description":18,"interventionNames":19},"Active rTMS + CPT","ACTIVE_COMPARATOR","30 minutes of 1 Hz rTMS to rDLPFC prior to each CPT session",[20,14],"Device: Sham rTMS",{"label":22,"type":17,"description":23,"interventionNames":24},"Active rTMS Alone","30 minutes of 1 Hz rTMS to rDLPFC at 1 session per week over 12 weeks",[13],[26,33,39],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DEVICE","Active rTMS","A Magstim Rapid2 Stimulator repetitive transcranial magnetic stimulation (rTMS) device will be used to deliver 1 hertz (Hz) stimulation to right dorsolateral prefrontal cortex (rDLPFC) at 110% of a participant's rTMS motor threshold. The device passes electric current through a coil generating an alternating magnetic field. When positioned over the skull, the changing magnetic field causes electromagnetic inducted current flow in brain regions subjacent to the coil. Magnetic pulses (1.5-2.0 Tesla) lasting 100-300 microseconds at 1 Hz will be used.\n\nMotor threshold will be defined by the TMS intensity to right motor region required to induce visually perceptible movement of the contralateral abductor pollicus brevis 50 percent of the time.",[22,9],[32],"1 Hz repetitive transcranial magnetic stimulation",{"type":27,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"Sham rTMS","A Magstim Rapid2 Stimulator repetitive transcranial magnetic stimulation (rTMS) device will be paired with sham coil. The sham coil will induce electrical current flow in the tissue above the skull but will not induce current flow in brain tissue. The sham coil will be placed over the right prefrontal scalp region to target current flow in rDLPFC. Magnetic pulses lasting for 100-300 microseconds at 1 Hz will be used.\n\nFor consistency across the rTMS conditions, motor threshold in the sham condition also will be determined by positioning the active rTMS coil over the right motor region and identifying the stimulation intensity required to induce visually perceptible movement of the contralateral abductor pollicus brevis 50 percent of the time.",[16],[38],"sham repetitive transcranial magnetic stimulation",{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"BEHAVIORAL","Cognitive Processing Therapy","Cognitive Processing Therapy (CPT) is an evidenced based, trauma-focused treatment for Posttraumatic Stress Disorder (PTSD). CPT is a recommended form of treatment in the Veterans Administration - Department of Defense Clinical Practice Guideline for PTSD. The CPT manual delineates the agenda for each of 12 sessions (60 minutes per session): 1) Introduction to CPT and Patient Education regarding PTSD, 2) Meaning of the Trauma, 3) Identification of Thoughts and Feelings related to the Trauma, 4) Remembering the Trauma, 5) Identification of Stuck points, 6) Challenging Questions about the Trauma, 7) Dysfunctional\u002FMaladaptive Thinking patterns related to the Trauma, 8) Safety Issues, 9) Trust Issues, 10) Power and Control Issues, 11) Self-Esteem Issues, and 12) Intimacy Issues.",[16,9],[45],"CPT",[47,50,53],{"name":48,"affiliation":5,"role":49},"John Hart, Jr., MD","PRINCIPAL_INVESTIGATOR",{"name":51,"affiliation":52,"role":49},"F. Andrew Kozel, MD","Florida State University",{"name":54,"affiliation":55,"role":49},"John Burruss, MD","Metrocare Services of Dallas",[57,63],{"name":58,"role":59,"phone":60,"phoneExt":61,"email":62},"Elizabeth \"Ellen\" Morris, PhD","CONTACT","214-883-3171",null,"neurolab@utdallas.edu",{"name":64,"role":59,"phone":65,"phoneExt":61,"email":62},"Jill Ritter, BS","972-883-3171",[67,86,100],{"facility":68,"status":69,"city":70,"state":71,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"Florida State University College of Medicine","RECRUITING","Tallahassee","Florida","32308","United States","US",{"type":76,"coordinates":77},"Point",[78,79],-84.28073,30.43826,{"lat":79,"lon":78},[82],{"name":83,"role":59,"phone":84,"phoneExt":61,"email":85},"FSU Neuromodulation","850-644-2824","FSUN@med.fsu.edu",{"facility":55,"status":69,"city":87,"state":88,"zip":89,"country":73,"countryCode":74,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"Addison","Texas","75001",{"type":76,"coordinates":91},[92,93],-96.82917,32.96179,{"lat":93,"lon":92},[96],{"name":97,"role":59,"phone":98,"phoneExt":61,"email":99},"Steven A Cohen Military Family Clinic at Metrocare","469-680-3500","MFC@MetrocareServices.org",{"facility":5,"status":69,"city":101,"state":88,"zip":102,"country":73,"countryCode":74,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"Dallas","75235",{"type":76,"coordinates":104},[105,106],-96.80667,32.78306,{"lat":106,"lon":105},[109,111,113,116],{"name":110,"role":59,"phone":65,"phoneExt":61,"email":62},"Celia Higginbotham",{"name":112,"role":59,"phone":65,"phoneExt":61,"email":62},"Crista Thyvelikakath, MA",{"name":114,"role":115,"phone":61,"phoneExt":61,"email":61},"Michael Motes, PhD","SUB_INVESTIGATOR",{"name":117,"role":115,"phone":61,"phoneExt":61,"email":61},"Gail Tillman, PhD",{"type":49,"investigatorFullName":119,"investigatorTitle":120,"investigatorAffiliation":5,"oldNameTitle":61,"oldOrganization":61},"John Hart, Jr.","Professor",[122,124,126,128],{"name":123,"class":6},"University of Texas Southwestern Medical Center",{"name":125,"class":6},"Johns Hopkins University",{"name":55,"class":127},"UNKNOWN",{"name":52,"class":6},"100357341","multi-site-confirmatory-efficacy-treatment-trial-of-combat-related-ptsd-100357341",false,"NCT03932773","Multi-site Confirmatory Efficacy Treatment Trial of Combat-related PTSD","Inclusion Criteria:\n\n* Veterans of Post-9\u002F11 military conflicts\n* with diagnosis of PTSD based on CAPS-5 related to Post-9\u002F11 military combat\n\nExclusion Criteria:\n\n* current enrollment in an acute experimental treatment for PTSD or trauma-focused psychotherapy treatment\n* PTSD-inducing trauma exposure occurring within the last 3 months prior to pre-enrollment evaluation\n* history of epilepsy or seizure disorder, a history of major head trauma,\n* any neurologic condition likely to increase risk of seizures,\n* brain tumors,\n* moderate to severe substance use disorder in last 3 months or any substance use that puts the participant at increased risk or significant impairment\n* stroke, and blood vessel abnormalities in the brain,\n* dementia,\n* Parkinson's disease, Huntington's chorea, or multiple sclerosis\n* a high suicide risk\n* a lifetime history of psychotic disorder or bipolar disorder\n* inability to stop taking any medication that significantly lowers the seizure threshold\n* pregnant or nursing\n* metal fragments in the head, or any metal objects in or near the head that cannot be safely removed\n* We will screen for a history of traumatic brain injury and exclude potential participants from the study if they have a history of severe TBI or are at high risk for seizures.\n* history of seizures\n* non-English speakers because not all of the screening forms, questionnaires, and tests are available in any language except for English\n* cardiac pacemaker, implanted medication pumps of any sort that would increase the risk of rTMS\n* any current medical condition that could preclude being able to safely participate in TMS treatment,\n* use of prescription medication or illegal substances that lower the seizure threshold\n* previous rTMS","ALL","18 Years","60 Years",{"count":139,"type":140},330,"ESTIMATED","INTERVENTIONAL",[143],"NA","The purpose of this study is to examine the benefits of combining repetitive Transcranial Magnetic Stimulation (rTMS) coupled with Cognitive Processing Therapy (CPT) in treating combat-related Posttraumatic Stress Disorder (PTSD) symptoms. The study will also examine change in depression, psychosocial functioning, and neurophysiological (i.e., electroencephalography and magnetic resonance images) measures.",[146],"Post Traumatic Stress Disorder",[148,149,150,45,151,152,153,154,155],"PTSD","post-traumatic stress disorder","military-related PTSD","cognitive processing therapy","rTMS","repetitive transcranial magnetic stimulation","combat","combat-related PTSD","2025-08-15",{"date":158,"type":159},"2025-08-22","ACTUAL",{"date":161,"type":159},"2019-05-01",{"date":163,"type":140},"2026-07-31",{"name":5,"class":6},3]