[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561860":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":36,"locations":42,"responsibleParty":68,"collaborators":30,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":30,"enrollmentInfo":81,"targetDuration":30,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":91,"overallStatus":45,"whyStopped":30,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Centre hospitalier de Ville-Evrard, France","OTHER",[8,13,17,21],{"label":9,"type":6,"description":10,"interventionNames":11},"Method 1","One stimulation session per day for 20 working days, so 4 weeks (frequency of 10 Hz, 80% 100% of motor threshold). Each session lasts 20 min. The duration of the train is 4 s, an inter-train of 56s.",[12],"Other: repetitive Transcranial Magnetic Stimulation",{"label":14,"type":6,"description":15,"interventionNames":16},"Method 2","Two stimulations sessions per day, with 1 hour apart, for 20 working days, so 4 weeks (frequency of 20 Hz, 100% of motor threshold).Each session lasts 28 min. The duration of the train of 10 s, an inter-train of 80s The total number of pulses is 40000 in 20 trains or 2000 per day.",[12],{"label":18,"type":6,"description":19,"interventionNames":20},"Method 3","Two stimulations session per day for 10 working days, so 2 weeks. The protocol is delivered in bursts containing 3 pulses at 50 Hz repeated at 200 ms intervals for 2 s (i.e., 5 Hz). Stimulation intensity is set at 80% of the idle motor threshold intensity",[12],{"label":22,"type":6,"description":23,"interventionNames":24},"Method 4","Five to ten sessions per day, 50 minutes apart, with 90% SM for 10 working days, so 2 weeks. 1 of stimuli every 20 ms (50Hz) repeated 3 times, this train itself repeated every 200 ms (5 Hz) or 60 cycles of 10 blocks of 3 stimuli. The duration of the train is 2 seconds with an inter-train of 8 seconds. So there are 1800 stimuli per session",[12],[26],{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"repetitive Transcranial Magnetic Stimulation","* Patient is in a chair.\n* Hearing protection will be implemented.\n* The corresponding targeting method will be implemented.\n* The stimulation coil will be set up according to the indications of the targeting method.\n* A caregiver is present throughout the session.\n* After the session, the patient is re-assessed clinically for possible adverse effects.\n* If an adverse reaction is objectified, a doctor on site, is quickly mobilized.",[9,14,18,22],null,[32],{"name":33,"affiliation":34,"role":35},"Dominique Januel","Clinical research unit, EPS Ville Evrard","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":30,"email":41},"Youcef Bencherif","CONTACT","+33 1 43 09 32 32","urc@epsve.fr",[43],{"facility":44,"status":45,"city":46,"state":30,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Etablissement Public de Santé de Ville-Evrard","RECRUITING","Neuilly-sur-Marne","93330","France","FR",{"type":51,"coordinates":52},"Point",[53,54],2.54903,48.85373,{"lat":54,"lon":53},[57,59,61,64,66],{"name":38,"role":39,"phone":40,"phoneExt":30,"email":58},"urcve1@gmail.com",{"name":60,"role":39,"phone":40,"phoneExt":30,"email":58},"Rusheentira Thavaseelan",{"name":62,"role":63,"phone":30,"phoneExt":30,"email":30},"Noomane BOUAZIZ, Dr.","SUB_INVESTIGATOR",{"name":65,"role":35,"phone":30,"phoneExt":30,"email":30},"Dominique JANUEL, Pr.",{"name":67,"role":63,"phone":30,"phoneExt":30,"email":30},"René BENADHIRA, Dr.",{"type":35,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Dominique JANUEL","Head of clinical research unit","100561860","treatment-of-negative-symptoms-of-schizophrenia-by-rtms-100561860",false,"NCT06595654","Treatment of Negative Symptoms of Schizophrenia by rTMS","Treatment of Negative Symptoms of Schizophrenia by Repetitive Transcranial Magnetic Stimulation: A Naturalistic Study","SN RENAT","Inclusion Criteria:\n\n* Patient over 18 years of age\n* Patient diagnosed with schizophrenia according to the DSM-V criteria (Diagnostic and Statistical Manual of Mental Disorder V5, 2013)\n* Stable drug treatment for at least 4 weeks\n* Presence or persistence of negative symptoms in the foreground:\n\nNegative PANSS score ⩾21, positive PANSS score ⩽24\n\n* Patient (or legal representative) willing to participate in the study and having signed an informed consent\n* Patient fluent in the French language\n* Affiliation to a social security scheme\n\nExclusion Criteria:\n\n* Present a contraindication to TMS: intracranial foreign body, unstabilized epilepsy, cochlear implant, pace-maker\n* Presence of an unstabilized medical condition\n* Pregnant woman\n* Woman of childbearing potential and without effective contraception\n* Breastfeeding woman","ALL","18 Years",{"count":82,"type":83},124,"ESTIMATED","INTERVENTIONAL",[86],"NA","The purpose of this study is to assess the effectiveness of rTMS on the negative symptoms of schizophrenia in real conditions. It will also provide a regulatory framework to rTMS treatments under these conditions. 4 types of rTMS protocols are proposed, allowing to adapt to patients and their tolerances.Treatment lasts between 2 and 4 weeks, with a follow-up period of 3 months after treatment to observe relapses.To assess the evolution of negative symptoms between baseline and the end of treatment, investigators use SANS (Scale for the Assessment of Negative Symptoms).",[89,90],"Schizophrenia","Negative Symptoms in Schizophrenia",[92,93,94,95],"rTMS","TMS","Transcranial magnetic stimulation","naturalistic","2024-09-12",{"date":98,"type":99},"2024-09-19","ACTUAL",{"date":101,"type":99},"2023-06-09",{"date":103,"type":83},"2028-03",{"name":5,"class":6},1]