[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100522694":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":32,"centralContacts":33,"locations":42,"responsibleParty":62,"collaborators":32,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":32,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":32,"overallStatus":45,"whyStopped":32,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Centre Hospitalier St Anne","OTHER",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"TUS - 5 min sessions, 5% duty cycle, 5 sessions\u002Fday (n=5)","EXPERIMENTAL","Low-intensity transcranial focused ultrasound stimulation of deep brain target, using a personalized acoustic lens to correct the aberrations induced by the skull. Sessions of 5 minutes at a 5% duty cycle, delivered 5 times per day for 5 days (25 sessions total).",[13],"Device: Transcranial Ultrasonic Stimulation prototype",{"label":15,"type":10,"description":16,"interventionNames":17},"TUS - 40 min sessions, 5% duty cycle, 2 sessions\u002Fday (n=7)","Low-intensity transcranial focused ultrasound stimulation of deep brain target, using a personalized acoustic lens to correct the aberrations induced by the skull. Sessions of 40 minutes at a 5% duty cycle, delivered 2 times per day for 5 days (10 sessions total).",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"TUS - 40 min sessions, 1% duty cycle, increased acoustic power, 2 sessions\u002Fday (n=10)","Low-intensity transcranial focused ultrasound stimulation of deep brain target, using a personalized acoustic lens to correct the aberrations induced by the skull. Sessions of 40 minutes at a 1% duty cycle with increased acoustic power, delivered 2 times per day for 5 days (10 sessions total).",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"TUS - 40 min sessions, 5% duty cycle, increased acoustic power, 2 sessions\u002Fday (n=10)","Low-intensity transcranial focused ultrasound stimulation of deep brain target, using a personalized acoustic lens to correct the aberrations induced by the skull. Sessions of 40 minutes at a 5% duty cycle with increased acoustic power, delivered 2 times per day for 5 days (10 sessions total).",[13],[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DEVICE","Transcranial Ultrasonic Stimulation prototype","Transcranial Ultrasonic Stimulation prototype delivers personalized low-intensity ultrasound stimulation",[19,15,23,9],null,[34,39],{"name":35,"role":36,"phone":37,"phoneExt":32,"email":38},"Marion PLAZE","CONTACT","+33 1 45 65 87 20","m.plaze@ghu-paris.fr",{"name":40,"role":36,"phone":32,"phoneExt":32,"email":41},"David ATTALI","d.attali@ghu-paris.fr",[43],{"facility":44,"status":45,"city":46,"state":32,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"GHU Sainte-Anne","RECRUITING","Paris","75014","France","FR",{"type":51,"coordinates":52},"Point",[53,54],2.3488,48.85341,{"lat":54,"lon":53},[57,60],{"name":58,"role":36,"phone":59,"phoneExt":32,"email":38},"Marion Plaze, MD, PHD","0145658720",{"name":61,"role":36,"phone":32,"phoneExt":32,"email":41},"David ATTALI, MD, PHD",{"type":63,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100522694","transcranial-ultrasonic-stimulation-in-treatment-resistant-depression--an-open-label-pilot-trial-100522694",false,"NCT06085950","Transcranial Ultrasonic Stimulation in Treatment-resistant Depression : an Open-label Pilot Trial","Transcranial Ultrasonic Stimulation in Treatment-resistant Depression: an Open-label Pilot Trial","StimulUS","Inclusion Criteria:\n\n* Age between 18 and 75 years,\n* Diagnosis of major depressive episode (MDE) as part of major depressive disorder as defined by DSM-5 criteria\n* Severe MDE (HDRS-17\\> 20)\n* Drug resistance to at least two well-conducted antidepressant treatment lines\n* With stable antidepressant treatment for at least 4 weeks before inclusion\n* Benefiting from a social security scheme\n* Having given their consent to participate\n\nExclusion Criteria:\n\n* Psychiatric history other than a mood disorder\n* Neurological history, including epilepsy and intracerebral calcifications\n* History of substance use disorder other than tobacco\n* Contraindication to brain MRI (pacemaker, neurostimulator, injury from metallic shine, …)\n* Compulsory psychiatric care\n* Protected adults, people under legal safeguard\n* Pregnant or breastfeeding woman\n* Women of childbearing age who do not have a negative pregnancy test and are not using contraception","ALL","18 Years","75 Years",{"count":76,"type":77},32,"ESTIMATED","INTERVENTIONAL",[80],"NA","The primary objective of this study is to optimize the protocol for the TUS administration in patients with TRD while gaining an initial impression of treatment efficacy.",[83],"Treatment Resistant Depression","2026-06-18",{"date":86,"type":87},"2026-06-22","ACTUAL",{"date":89,"type":87},"2023-05-09",{"date":91,"type":77},"2028-06",{"name":5,"class":6},1]