[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659318":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":31,"studyPopulation":18,"armGroups":32,"interventions":48,"overallOfficials":54,"centralContacts":58,"locations":68,"responsibleParty":88,"collaborators":91,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":96,"sex":102,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":18,"studyType":108,"phases":109,"briefSummary":111,"conditions":112,"keywords":116,"overallStatus":121,"whyStopped":18,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"Mayo Clinic","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Feasibility of closed-loop EEG guided iTBS in adult participants with MDD.","Participant retention and completion rate of 80% or more at 4 and 6 weeks of treatment in patients receiving closed-loop guided iTBS","6 weeks and 12 weeks post-treatment",[14],{"measure":15,"description":16,"timeFrame":17},"Change in Hamilton Depression Rating Scale (HDRS-17)","Closed-loop iTBS delivered to the peak theta rhythm will have greater improvements in depressive symptom severity as assessed with the HDRS as compared to the participants in the trough (n=20) and random (n=20) delivered iTBS.","Baseline through Week 18",null,{"allocation":20,"interventionModel":21,"interventionModelDescription":22,"primaryPurpose":23,"observationalModel":18,"timePerspective":18,"maskingInfo":24},"RANDOMIZED","PARALLEL","Randomized Double Blind Trial","TREATMENT",{"masking":25,"maskingDescription":26,"whoMasked":27},"TRIPLE","Participants and clinical outcome assessors are blinded to treatment assignment. A designated unblinded study team member operates the EEG-guided stimulation software and is responsible for implementing the assigned treatment condition. All treatment arms involve active intermittent theta burst stimulation delivered using identical equipment and procedures, including EEG cap placement, which helps maintain participant blinding. Clinical raters are not present during treatment sessions and remain blinded throughout study participation.",[28,29,30],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR","This is a randomized, double-blind, 3 arm trial with a parallel design. All patients will receive an FDA cleared form of TMS called intermittent theta burst (iTBS) but will be randomized to 1) Closed-loop TMS-EEG with stimulation bursts delivered at the trough of theta waves, 2) Closed- loop TMS-EEG with stimulation bursts delivered at the peak of theta waves or 3) Closed-loop TMS-EEG random phase TMS delivery (control stimulation). Patients in all 3 study arms will wear EEG caps and undergo similar procedures to facilitate blinding. Blinded clinical raters will collect depression symptom severity measures at screening, baseline, and weekly for 6 weeks followed by monthly follow-up visits for 3 months to assess for delayed responses to treatment. The iTBS will be delivered with a MagVenture Cool B70 coil and X100 stimulator. TBS treatment will be delivered once daily (5 days per week for 6 weeks) to the left DLPFC at 120% MT, 600 pulses per session. The Localite system will provide neuronavigation for treatment site localization with the participant's structural MRI or in patients that cannot obtain an MRI, the provided standard MNI atlas. Depressive symptom severity will be assessed weekly with the 17-item Hamilton Depression Rating Scale (HDRS), the Montgomery-Asberg Depression Rating Scale (MADRS), a patient-reported Patient Health Questionnaire (PHQ-9)55, and a Generalized Anxiety Disorder 7-time scale (GAD-7)56. Patients will continue to receive any standard clinical psychotherapy at the same frequency and will continue current psychotropic medications at the current dose consistently for the duration of the study. Clinical assessments visits will take place during the last treatment day (treatment 5) of every week for 6 weeks of treatment. Follow-up assessments will be collected in person or remotely (via zoom or telephone appointment) based on patient preference.",[33,39,43],{"label":34,"type":35,"description":36,"interventionNames":37},"Peak Theta Closed-Loop iTBS","EXPERIMENTAL","Participants receive EEG-guided intermittent theta burst stimulation (iTBS) delivered to the left dorsolateral prefrontal cortex (DLPFC). Stimulation bursts are synchronized to the peak of the participant's individual theta oscillations. Treatment is administered once daily, 5 days per week, for 6 weeks (30 sessions total).",[38],"Device: MagVenture TMS Therapy System with Localite Navigation System and actiCHamp EEG",{"label":40,"type":35,"description":41,"interventionNames":42},"Trough Theta Closed-Loop iTBS","Participants receive EEG-guided iTBS delivered to the left DLPFC with stimulation bursts synchronized to the trough of individual theta oscillations. Treatment is administered once daily, 5 days per week, for 6 weeks (30 sessions total)",[38],{"label":44,"type":45,"description":46,"interventionNames":47},"Random Phase iTBS","ACTIVE_COMPARATOR","Participants receive EEG-guided iTBS delivered to the left DLPFC with stimulation occurring at a random phase of theta oscillations. Treatment is administered once daily, 5 days per week, for 6 weeks (30 sessions total). This arm serves as the reference condition.",[38],[49],{"type":50,"name":51,"description":52,"armGroupLabels":53,"otherNames":18},"DEVICE","MagVenture TMS Therapy System with Localite Navigation System and actiCHamp EEG","The MagVenture TMS Therapy System is based on the use of intermittent theta burst stimulation, or iTBS. This novel TMS protocol delivers treatment in only 3 minutes and is based on a patterned TMS paradigm delivered to the left-dorsolateral prefrontal cortex (LDPFC) at 120% of resting motor threshold (MT). It consists of bursts of 3 pulses at 50 Hz, with bursts repeated at 5 Hz, in a duty cycle of 2s on, 8 s off, over 3 minutes and 9 seconds, and a total of 600 pulses.\n\nFor peak or trough iTBS, stimulation will consist of 3 pulses at 50 Hz delivered at intervals of their individual theta rhythm (e.g. 200 msec for a 5Hz oscillation) followed by an 8 second rest period. The pulses will be aligned to either the peak or the trough of the theta rhythm at the beginning of each pulse train. The TMS therapy will be delivered to the Left DLPFC at 120% of resting motor threshold (MT) daily for 5 days per week, for 6 weeks.",[34,44,40],[55],{"name":56,"affiliation":5,"role":57},"Paul E Croarkin, DO, MS","PRINCIPAL_INVESTIGATOR",[59,64],{"name":60,"role":61,"phone":62,"phoneExt":18,"email":63},"Courtney Caves","CONTACT","(507)696-2972","wolf.courtney@mayo.edu",{"name":65,"role":61,"phone":66,"phoneExt":18,"email":67},"Sarah Purdy","507-266-3303","purdy.sarah@mayo.edu",[69],{"facility":5,"status":18,"city":70,"state":71,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"Rochester","Minnesota","55905","United States","US",{"type":76,"coordinates":77},"Point",[78,79],-92.4699,44.02163,{"lat":79,"lon":78},[82,85,86],{"name":60,"role":61,"phone":83,"phoneExt":18,"email":84},"507-255-0624","CLEOPATRA@mayo.edu",{"name":65,"role":61,"phone":66,"phoneExt":18,"email":84},{"name":87,"role":57,"phone":18,"phoneExt":18,"email":18},"Paul Croarkin, DO, MS",{"type":57,"investigatorFullName":89,"investigatorTitle":90,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Paul E. Croarkin","Principal Investigator",[92],{"name":93,"class":6},"University of Minnesota","100659318","eeg-guided-transcranial-magnetic-stimulation-for-adults-with-depression-100659318",false,"NCT07862205","EEG-Guided Transcranial Magnetic Stimulation for Adults With Depression","Closed-Loop Electroencephalography Optimized Transcranial Magnetic Stimulation Pilot Study for Advanced Treatment Outcomes in Adults With Major Depressive Disorder","CLEOPATRA","Inclusion Criteria:\n\n* Outpatients\n* Voluntary patient seeking treatment with the capacity to consent\n* 22-60 years of age\n* Have Major Depressive Disorder (MDD) single or recurrent episodes confirmed with the Mini-International Neuropsychiatric Interview (MINI)57\n* Failed to achieve a clinical response to an adequately dosed antidepressant as assessed with an Antidepressant Treatment History Form score of 3 or greater in the current episode or have had 2 separate trials of antidepressants that were intolerable\n* Have a score of 18 or higher on the Hamilton Depression Rating Scale (17 item) HDRS\n* In a current episode of MDD with duration of at least 4 weeks but less than 2 years\n* Have no initiation or dose change in any psychotropic medication or for the 4 weeks prior to screening\n* Have no clinically significant changes (as determined by the study investigators) in psychotherapeutic interventions for the 4 weeks prior to screening Can safely undergo TMS treatment based on the TMS Adult Safety Screen questionnaire\n* On a medically acceptable form of birth control if capable of becoming pregnant\n* Are able to adhere to the protocol and treatment schedule\n* Currently and throughout study participation is under the care of a licensed psychiatrist and\u002For other mental health care provider and agrees to promptly inform the investigator or study staff of any change in such provider(s).\n* Agrees to allow any and all forms of communication between the investigators and study staff with any healthcare provider who has provided service to the patient\u002Fparticipant within at least two years of study enrollment for the purposes of eligibility confirmation or in case of a safety event.\n* Agrees to provide the name and verifiable contact information (email and mailing addresses, mobile and land-line phone numbers, as applicable) of at least two persons 22 years or older who reside within reasonable driving time of the patient's home address. Participant also agrees that research personnel are at liberty to contact these individuals if the participant is unable to be contacted.\n\nExclusion Criteria:\n\n* Have a history of a substance use disorder (including alcohol)\n* Within the past 3 months have a major medical illness, intracranial lesion or increased intracranial pressure, prior ischemic or hemorrhagic stroke, neurologic conditions with structural cerebral damage, stroke, multiple sclerosis, traumatic brain injury, epilepsy, a personal history of a seizure, or individuals with a family history of epilepsy or seizure in a first degree relative (please note that an individual with a first-degree relative with a history of epilepsy, or one or more seizures does not need to be excluded if the cause of epilepsy or seizure(s) is non-genetic (i.e., \"non-idiopathic\"), Alzheimer's and other neurodegenerative diseases, meningoencephalitis or intracerebral abscess, parenchymal or leptomeningeal cancers), moderate to severe heart disease, cardiac pacemaker, implanted devices, or implanted medication pumps\n* Contraindications for TMS or MRI\n* Have active suicidal intent, as determined by the Principal Investigator (PI) and\u002For is considered a moderate-high risk of suicide according to the Columbia-Suicide Severity Rating Scale (C-SSRS) Screen Version - Recent (i.e., answers YES to Question 3 and NO to Question 6 (Moderate risk) or YES to Question 4, 5, or 6 (High risk))4 by the PI. (Columbia Suicide Severity Rating Scale.\n* Pregnant and lactating patients\n* As determined by the Principal Investigator (PI), has: (a) a lifetime history of mania or hypomania symptoms from any cause; (b) a medical condition or diagnosis, within 1 year of screening, that seems somewhat likely to cause such symptoms; or (c) scores 12 on the Young Mania Rating Scale.\n* Based on the MINI interview have a lifetime diagnosis of bipolar I, bipolar II, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or any current psychotic symptoms.\n* Patients taking bupropion\u002FWellbutrin or antipsychotics are excluded","ALL","22 Years","60 Years",{"count":106,"type":107},60,"ESTIMATED","INTERVENTIONAL",[110],"NA","The purpose of this research is to see if an experimental treatment for depression called intermittent theta burst stimulation (iTBS), a form of transcranial magnetic stimulation (TMS) can be improved for better results using electroencephalography (EEG) recordings (brain waves) for individuals with Major Depressive Disorder (MDD).\n\nThis is a feasibility study to test a \"closed-loop\" procedure which guides the timing of this FDA-cleared form of TMS. Each participant will receive an active experimental treatment, and the timing of the TMS pulses will be at one of three phases in the brain wave of interest.",[113,114,115],"Major Depressive Disorder (MDD)","Treatment Resistant Depression","Major Depression",[117,118,119,120],"Transcranial Magnetic Stimulation (TMS)","Major Depressive Disorder","Intermittent Theta Burst Stimulation (iTBS)","Adults with MDD","NOT_YET_RECRUITING","2026-10-01",{"date":124,"type":125},"2026-10-07","ACTUAL",{"date":127,"type":107},"2026-11",{"date":129,"type":107},"2029-11",{"name":5,"class":6},1]