[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646353":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":29,"locations":40,"responsibleParty":83,"collaborators":85,"id":90,"slug":91,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":34,"eligibilityCriteria":96,"healthyVolunteers":92,"sex":97,"minAge":98,"maxAge":99,"enrollmentInfo":100,"targetDuration":34,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":113,"whyStopped":34,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Aarhus University Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"EMDR with add-on iTBS","EXPERIMENTAL","Participants receive weekly Eye Movement Desensitization and Reprocessing (EMDR) therapy for up to 16 weeks. After seven EMDR sessions, treatment response is assessed using the Clinical Global Impression-Improvement scale (CGI-I). Participants with insufficient response receive adjunctive intermittent theta-burst stimulation (iTBS) to the right dorsolateral prefrontal cortex for 20 sessions over 4 weeks while continuing EMDR. Participants with sufficient response continue EMDR treatment alone.",[13],"Device: Intermittent Theta-Burst Stimulation (iTBS)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Intermittent Theta-Burst Stimulation (iTBS)","All enrolled participants begin standardized EMDR treatment. Participants who show insufficient clinical improvement after seven EMDR sessions receive adjunctive intermittent theta-burst stimulation (iTBS) while continuing EMDR. Participants who show sufficient improvement continue EMDR alone.",[9],[21],"Behavioral: Eye Movement Desensitization and Reprocessing (EMDR)",[23,26],{"name":24,"affiliation":5,"role":25},"Pernille Kølbæk","STUDY_CHAIR",{"name":27,"affiliation":5,"role":28},"Ana Lisa Carmo","PRINCIPAL_INVESTIGATOR",[30,36],{"name":31,"role":32,"phone":33,"phoneExt":34,"email":35},"Pernille Kølbæk, MD PhD","CONTACT","004561397432",null,"perpet@rm.dk",{"name":37,"role":32,"phone":38,"phoneExt":34,"email":39},"Ana Lisa Carmo, Psychiatrist","0045 61155056","ANAMAR@rm.dk",[41,55,70],{"facility":5,"status":34,"city":42,"state":34,"zip":34,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Aarhus N","Denmark","DK",{"type":46,"coordinates":47},"Point",[48,49],10.17317,56.20367,{"lat":49,"lon":48},[52,53,54],{"name":31,"role":32,"phone":33,"phoneExt":34,"email":35},{"name":37,"role":32,"phone":38,"phoneExt":34,"email":39},{"name":37,"role":28,"phone":34,"phoneExt":34,"email":34},{"facility":56,"status":34,"city":57,"state":34,"zip":34,"country":43,"countryCode":44,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"Regional Psychiatry Horsens","Horsens",{"type":46,"coordinates":59},[60,61],9.85034,55.86066,{"lat":61,"lon":60},[64,68,69],{"name":65,"role":32,"phone":66,"phoneExt":34,"email":67},"Thea Grønfeldt, Psychiatrist","00457847 9258","theafaer@rm.dk",{"name":31,"role":32,"phone":33,"phoneExt":34,"email":35},{"name":31,"role":28,"phone":34,"phoneExt":34,"email":34},{"facility":71,"status":34,"city":72,"state":34,"zip":34,"country":43,"countryCode":44,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Regional Psychiatry Central Jutland","Viborg",{"type":46,"coordinates":74},[75,76],9.40201,56.45319,{"lat":76,"lon":75},[79,81,82],{"name":37,"role":32,"phone":80,"phoneExt":34,"email":39},"004561155056",{"name":31,"role":32,"phone":33,"phoneExt":34,"email":35},{"name":37,"role":28,"phone":34,"phoneExt":34,"email":34},{"type":28,"investigatorFullName":24,"investigatorTitle":84,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"Regional Clinical Research Coordinator, Associate professor",[86,88],{"name":87,"class":6},"Viborg Regional Hospital",{"name":89,"class":6},"Regionshospitalet Horsens","100646353","intermittent-theta-burst-stimulation-itbs-as-an-add-on-to-eye-movement-desensitization-and-reprocessing-emdr-in-the-treatment-of-post-traumatic-stress-disorder-ptsd-100646353",false,"NCT07693088","Intermittent Theta-Burst Stimulation (iTBS) as an add-on to Eye Movement Desensitization and Reprocessing (EMDR) in the Treatment of Post-traumatic Stress Disorder (PTSD)","Intermittent Theta-Burst Stimulation (iTBS) as an add-on to Eye Movement Desensitization and Reprocessing (EMDR) in the Treatment of Post-traumatic Stress Disorder (PTSD): An Open-label Pilot Study","Inclusion Criteria:\n\n* Age 18-70 years\n* ICD-10 criteria for PTSD (F43.1)\n* A minimum total score of 4 (moderately ill) on the Clinical Global Impression-Severity (CGI-S)\n* Likely to be able to complete trial participation (16 weeks) without modifications to psychopharmacological treatment, as per the referring doctor's or psychologist's assessment\n* Participants must be able and willing to abstain from alcohol consumption during the iTBS treatment period, as required by the TMS Safety Checklist.\n\nExclusion Criteria:\n\n* Organic mental disorders (F0)\n* Currently fulfills the criteria of Active psychoactive substance use or dependence (F1)\n* Schizophrenia, schizotypal and delusional disorders (F2), manic episode (F30), or bipolar affective disorder (F31); iv) Mental retardation (estimated IQ \\\u003C70, as per the referring doctor's or psychologist's assessment)\n* Active suicidality\n* Any ongoing involuntary\u002Fcoercive measures\n* Any contraindications listed on the TMS Safety Checklist","ALL","18 Years","70 Years",{"count":101,"type":102},15,"ESTIMATED","INTERVENTIONAL",[105],"NA","This open-label pilot study will evaluate the feasibility, safety, tolerability, and preliminary clinical outcomes of adding intermittent theta-burst stimulation (iTBS) to Eye Movement Desensitization and Reprocessing (EMDR) therapy in adults with post-traumatic stress disorder (PTSD), who show insufficient improvement after an initial course of EMDR.\n\nParticipants will receive weekly EMDR therapy. After seven EMDR sessions, treatment response will be assessed using the Clinical Global Impression-Improvement scale (CGI-I). Participants with insufficient response will receive add-on iTBS targeted to the right dorsolateral prefrontal cortex (DLPFC) for four weeks while continuing EMDR. Feasibility outcomes include adherence, treatment completion, and dropout rates. Clinical outcomes will include clinician-rated and self-reported measures of PTSD symptoms, depressive symptoms, well-being, and adverse events.",[108],"PTSD - Post Traumatic Stress Disorder",[110,111,17,112],"Eye Movement Desensitization Reprocessing","Transcranial Magnetic Stimulation","Post-Traumatic Stress Disorder","NOT_YET_RECRUITING","2026-07-07",{"date":116,"type":117},"2026-07-09","ACTUAL",{"date":119,"type":102},"2026-07",{"date":121,"type":102},"2027-06",{"name":5,"class":6},3]