[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627492":3},{"organization":4,"outcomesModule":7,"designInfo":59,"detailedDescription":58,"studyPopulation":62,"armGroups":63,"interventions":69,"overallOfficials":58,"centralContacts":75,"locations":81,"responsibleParty":120,"collaborators":58,"id":122,"slug":58,"hasResults":123,"nctId":124,"briefTitle":125,"officialTitle":125,"acronym":58,"eligibilityCriteria":126,"healthyVolunteers":123,"sex":127,"minAge":128,"maxAge":58,"enrollmentInfo":129,"targetDuration":132,"studyType":133,"phases":58,"briefSummary":134,"conditions":135,"keywords":137,"overallStatus":84,"whyStopped":58,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":150},{"fullName":5,"class":6},"Vastra Gotaland Region","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":58},[9],{"measure":10,"description":11,"timeFrame":12},"Difference in MADRS-S from baseline to six weeks after first iTBS treatment","The self-rating version of the Montgomery-Asberg Depression Rating Scale (MADRS-S) is a rating scale (0-54 points), where a higher score indicates worse depressive symptoms","6 weeks",[14,17,20,23,26,28,31,33,35,37,40,42,44,46,49,52,54,56],{"measure":15,"description":11,"timeFrame":16},"Difference in MADRS-S from baseline to after last iTBS treatment","2 weeks",{"measure":18,"description":11,"timeFrame":19},"Difference in MADRS-S from baseline to twelve weeks after first iTBS treatment","12 weeks",{"measure":21,"description":11,"timeFrame":22},"Difference in MADRS-S from baseline to six months after first iTBS treatment","6 months",{"measure":24,"description":25,"timeFrame":19},"Difference in SDS from baseline to twelve weeks after first iTBS treatment","The Sheehan Disability Scale (SDS) is a self-rating assessment (0-30 points), where a higher score indicates more pronounced functional impairment",{"measure":27,"description":25,"timeFrame":22},"Difference in SDS from baseline to six months after first iTBS treatment",{"measure":29,"description":30,"timeFrame":16},"Difference in EQ-VAS from baseline to after last iTBS treatment","The EQ-5D visual analogue scale (EQ-VAS) is a self-rating assessment (VAS 0-100 points), where a higher (VAS) score indicates a higher health-related quality of life",{"measure":32,"description":30,"timeFrame":12},"Difference in EQ-VAS from baseline to six weeks after first iTBS treatment",{"measure":34,"description":30,"timeFrame":19},"Difference in EQ-VAS from baseline to twelve weeks after first iTBS treatment",{"measure":36,"description":30,"timeFrame":22},"Difference in EQ-VAS from baseline to six months after first iTBS treatment",{"measure":38,"description":39,"timeFrame":16},"Difference in reported potential side effects from baseline to after last iTBS treatment","A patient-reported form including the most commonly reported side effects of rTMS.",{"measure":41,"description":39,"timeFrame":12},"Difference in reported potential side effects from baseline to six weeks after first iTBS treatment",{"measure":43,"description":39,"timeFrame":19},"Difference in reported potential side effects from baseline to twelve weeks after first iTBS treatment",{"measure":45,"description":39,"timeFrame":22},"Difference in reported potential side effects from baseline to six months after first iTBS treatment",{"measure":47,"description":48,"timeFrame":16},"rTMS associated pain experience","A patient-reported form rating experience of pain (scale 1 to 10) during rTMS treatment. Performed after last treatment series",{"measure":50,"description":51,"timeFrame":16},"Number of patients in remission after last iTBS treatment","A patient with a MADRS-S score of \\\u003C 10 is considered to be in remission",{"measure":53,"description":51,"timeFrame":12},"Number of patients in remission six weeks after first iTBS treatment",{"measure":55,"description":51,"timeFrame":19},"Number of patients in remission twelve weeks after first iTBS treatment",{"measure":57,"description":51,"timeFrame":22},"Number of patients in remission six months after first iTBS treatment",null,{"allocation":58,"interventionModel":58,"interventionModelDescription":58,"primaryPurpose":58,"observationalModel":60,"timePerspective":61,"maskingInfo":58},"COHORT","PROSPECTIVE","Patients referred for AiTBS treatment at participating study sites will be invited to participate in the study.",[64],{"label":65,"type":58,"description":66,"interventionNames":67},"1W-AiTBS","Magnetic pulses of 80% of visual motor threshold applied in triplets of 50 Hz bursts, repeated at 5 Hz; 2 seconds on and 8 seconds off; 600 pulses per session; total duration of 3 min 20 s over the left DLPFC (F3), given in a maximum of 8 sessions per day (\\>15 min interval), total of 30 treatments on total of 10 week days.",[68],"Device: iTBS (intermittent theta-burst stimulation)",[70],{"type":71,"name":72,"description":73,"armGroupLabels":74,"otherNames":58},"DEVICE","iTBS (intermittent theta-burst stimulation)","The iTBS treatment is a type of rTMS (repetitive transcranial magnetic stimulation), delivered with MagPro R30 stimulator and a conventional cool-B65 coil. The iTBS treatment is applied to over the dorsolateral prefrontal cortex using a standardized measuring of the anatomical landmark F3 from the 10-20 positioning system. The coil is positioned with the handle at in a 45 degree angle from the midline. The centre of the butterfly is placed towards the patient head.",[65],[76],{"name":77,"role":78,"phone":79,"phoneExt":58,"email":80},"Melker Hagsäter, MD, MSc, PhD, PhD","CONTACT","+46 3039 8000","melker.hagsater@vgregion.se",[82,98,110],{"facility":83,"status":84,"city":85,"state":58,"zip":58,"country":86,"countryCode":87,"cosmosGeoPoint":88,"geoPoint":93,"contacts":94},"Sahlgrenska University Hospital","RECRUITING","Gothenburg","Sweden","SE",{"type":89,"coordinates":90},"Point",[91,92],11.96679,57.70716,{"lat":92,"lon":91},[95],{"name":96,"role":78,"phone":79,"phoneExt":58,"email":97},"Caroline Wass","caroline.wass@vgregion.se",{"facility":99,"status":84,"city":100,"state":58,"zip":58,"country":86,"countryCode":87,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Kungälv Hospital, Kungälv","Kungälv",{"type":89,"coordinates":102},[103,104],11.98054,57.87096,{"lat":104,"lon":103},[107],{"name":108,"role":78,"phone":109,"phoneExt":58,"email":80},"Melker Hagsäter","+46 10441 00 00",{"facility":111,"status":84,"city":112,"state":58,"zip":58,"country":86,"countryCode":87,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"Central Hospital Växjö","Vaxjo",{"type":89,"coordinates":114},[115,116],14.80906,56.87767,{"lat":116,"lon":115},[119],{"name":108,"role":78,"phone":109,"phoneExt":58,"email":80},{"type":121,"investigatorFullName":58,"investigatorTitle":58,"investigatorAffiliation":58,"oldNameTitle":58,"oldOrganization":58},"SPONSOR","100627492",false,"NCT07449338","Prospective Cohort Study of Response and Tolerability of Accelerated Intermittent Theta-burst Stimulation (1W-AiTBS)","Inclusion Criteria:\n\n* diagnosis of depression verified through a Mini International Neuropsychiatric Interview (M.I.N.I.)\n* provision of signed informed consent form\n* indication for TMS is depression\n\nExclusion Criteria:\n\n* conductive ferromagnetic or other metals implanted in the head or within 30 cm of the treatment coil\n* implanted device that is activated or controlled in any way by physiological signals\n* implanted mediation pumps\n* intracardiac lines, even when removed\n* any condition that seriously increases the risk of non-compliance or loss of follow-up","ALL","18 Years",{"count":130,"type":131},36,"ESTIMATED","6 Months","OBSERVATIONAL","Intermittent theta-burst stimulation (iTBS), a variant of repetitive transcranial magnetic stimulation (rTMS), is a well-documented treatment for depression. The aim of this study is to evaluate the effectiveness of an accelerated iTBS protocol (1W-AiTBS) in routine clinical practice. In the accelerated protocol, patients receive 600 pulses per session, for a total of 30 sessions administered over 5-14 treatment days. Patient inclusion will take place over a maximum period of 1.5 years, with a maximum sample size of 150 patients. The target sample size is at least 36 patients. Patients will complete self-rating questionnaires at screening, before and after treatment, and at 6 weeks, 12 weeks, and 6 months from the first day of treatment.",[136],"Depression",[138,139,140],"iTBS","rTMS","depression","2026-05-25",{"date":143,"type":144},"2026-05-28","ACTUAL",{"date":146,"type":144},"2026-03-01",{"date":148,"type":131},"2027-03-01",{"name":5,"class":6},3]