[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633551":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":38,"centralContacts":42,"locations":48,"responsibleParty":61,"collaborators":64,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":31,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":31,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":91,"whyStopped":31,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Stanford University","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Personalized iTBS","EXPERIMENTAL","Participants receive 10 sessions of iTBS using individually selected pulse count and intensity parameters identified during a prior screening phase as producing the greatest suppression of the EL-TEP biomarker.",[13],"Device: Personalized iTBS",{"label":15,"type":16,"description":17,"interventionNames":18},"Non-Personalized iTBS","ACTIVE_COMPARATOR","Participants receive 10 sessions of iTBS using standard fixed parameters (1800 pulses, 120% resting motor threshold).",[19],"Device: Non-Personalized iTBS",{"label":21,"type":22,"description":23,"interventionNames":24},"Sham iTBS","SHAM_COMPARATOR","Participants receive 10 sessions of sham iTBS, matched in timing and scalp sensation to active stimulation using a shielded coil and scalp electrodes.",[25],"Device: Sham iTBS",[27,32,35],{"type":28,"name":9,"description":29,"armGroupLabels":30,"otherNames":31},"DEVICE","Intermittent theta burst stimulation delivered to the left dorsolateral prefrontal cortex using individualized pulse count (600, 1200, or 1800 pulses) and intensity (90% or 120% rMT) determined by EL-TEP screening.",[9],null,{"type":28,"name":15,"description":33,"armGroupLabels":34,"otherNames":31},"Intermittent theta burst stimulation delivered to the left dorsolateral prefrontal cortex at fixed parameters: 1800 pulses, 120% resting motor threshold.",[15],{"type":28,"name":21,"description":36,"armGroupLabels":37,"otherNames":31},"Inactive sham stimulation using a shielded coil with electrical scalp stimulation to mimic sensory experience of active iTBS.",[21],[39],{"name":40,"affiliation":5,"role":41},"Corey J Keller, MD, PhD","PRINCIPAL_INVESTIGATOR",[43],{"name":44,"role":45,"phone":46,"phoneExt":31,"email":47},"Jade T Truong, BS","CONTACT","(408) 831-2366","kellerlab@stanford.edu",[49],{"facility":5,"status":31,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":31},"Stanford","California","94305","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-122.16608,37.42411,{"lat":59,"lon":58},{"type":41,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Corey Keller","Associate Professor",[65],{"name":66,"class":67},"National Institute of Mental Health (NIMH)","NIH","100633551","early-brainwave-biomarkers-for-personalized-neuromodulation-in-treatment-resistant-depression-100633551",false,"NCT07528157","Early Brainwave Biomarkers for Personalized Neuromodulation in Treatment-resistant Depression","Early TMS-EEG Potentials as Biomarkers for Personalized Neuromodulation in Treatment-Resistant Depression (R61 Phase)","Inclusion Criteria:\n\n* Aged 18-65 years\n* Clinical diagnosis of Major Depressive Disorder (MDD), confirmed by structured clinical interview\n* Current moderate-to-severe depressive episode (MADRS score ≥ 20)\n* Moderate-to-severe treatment resistance, assessed using the Maudsley Staging Method\n* Able to comprehend English sufficiently to complete study procedures and assessments\n* Able to maintain stable antidepressant regimen or remain medication-free for at least 4 weeks prior to and during the study\n\nExclusion Criteria:\n\n* Primary psychiatric diagnosis other than MDD\n* Contraindications to MRI (e.g., implanted metal)\n* Conditions or medications that may increase risk associated with TMS\n* Prior exposure to repetitive TMS (rTMS)\n* Non-response to electroconvulsive therapy (ECT)\n* History of psychosurgery for depression\n* High suicidal risk as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)","ALL","18 Years","65 Years",{"count":79,"type":80},80,"ESTIMATED","INTERVENTIONAL",[83],"NA","This study tests whether a brain stimulation treatment for depression called intermittent theta burst stimulation (iTBS) can be improved by tailoring it to each individual. A type of brain signal measured with electroencephalography (EEG) after a single pulse of brain stimulation, called an early local TMS-evoked potential (EL-TEP), is used to identify which stimulation settings work best for each participant. The investigators will compare individualized (personalized) iTBS settings to standard (non-personalized) settings and to inactive (sham) stimulation. Participants are adults with treatment-resistant depression.",[86,87],"Major Depressive Disorder","Treatment Resistant Depression",[89,90],"tms","eeg","NOT_YET_RECRUITING","2026-04-07",{"date":94,"type":95},"2026-04-14","ACTUAL",{"date":97,"type":80},"2026-06-01",{"date":99,"type":80},"2027-12-31",{"name":5,"class":6},1]