[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100542334":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":25,"locations":26,"responsibleParty":57,"collaborators":61,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":25,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":25,"overallStatus":29,"whyStopped":25,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"University of Geneva, Switzerland","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Active","ACTIVE_COMPARATOR","Active intermittent theta burst stimulation (iTBS) to the cerebellum at 80% of active motor threshold.",[13],"Device: iTBS",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Sham intermittent theta burst stimulation (iTBS) to the cerebellum",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","iTBS","Intermittent Theta Burst Stimulation (iTBS) pattern consisting of 2 s trains of 3 pulses at 50 Hz, repeated at 5 Hz, every 10s for a total of 600 pulses for up to 8 sessions daily for 5 days",[9,15],null,[27,46],{"facility":28,"status":29,"city":30,"state":25,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Campus Biotech","RECRUITING","Geneva","1202","Switzerland","CH",{"type":35,"coordinates":36},"Point",[37,38],6.14569,46.20222,{"lat":38,"lon":37},[41],{"name":42,"role":43,"phone":44,"phoneExt":25,"email":45},"principal investigator","CONTACT","0041 58 944 03 00","etude-tms@unige.ch",{"facility":47,"status":48,"city":30,"state":25,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":49,"geoPoint":51,"contacts":52},"Indrit Bègue","NOT_YET_RECRUITING",{"type":35,"coordinates":50},[37,38],{"lat":38,"lon":37},[53],{"name":54,"role":43,"phone":55,"phoneExt":25,"email":56},"Indrit Bègue, MD, PhD","+41589440300","indrit.begue@unige.ch",{"type":58,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Indrit Begue","Assistant Professor",[62],{"name":5,"class":6},"100542334","brain-circuitry-therapeutics-for-schizophrenia-100542334",false,"NCT06341517","Brain Circuitry Therapeutics for Schizophrenia","Brain Circuitry Therapeutics for Schizophrenia - A Cross-species Longitudinal Randomized Controlled Clinical Study to Treat Negative Symptoms of Schizophrenia Using Non-invasive Stimulation of the Cerebellum","ATHENA","Inclusion Criteria:\n\n* Inclusion criteria\n\n  * Capable of giving informed consent as evaluated by the treating psychiatrist\n  * Informed Consent signed by the subject\n  * Patients aged 18 - 65 years diagnosed with a schizophrenia spectrum disorder (including schizophrenia, schizoaffective or non-organic psychosis, psychotic disorder NOS) according to DSM-5 criteria\n  * Clinically stable condition judged by their treating psychiatrist\n  * Background antipsychotic medication treatments have remained unchanged for at least 4 weeks\n  * No hospitalization in acute psychiatry ward at least 3 months prior to study entry\n\nSpecific exclusion criteria related to psychopathology\n\n* Comorbid and clinically active current major depressive episode determined by the treating psychiatrist.\n* Active psychotic symptoms. In particular, patients that at Baseline have a PANSS scores of more than 4 in any of the following PANSS items: delusions, suspiciousness\u002Fpersecution and hallucinatory behaviour will be considered not stable enough to participate.\n* Significant extrapyramidal side-effects quantified by total score of mSAS \\> 12.\n* Increased sedation due to use of medication (slowing, drowsiness, slurred speech etc.)\n* Active daily use of substances (i.e. cocaine), including for therapeutically medical purposes (e.g., methadone substitution)\n\nExclusion criteria related to MRI or TMS\n\n* History of fainting spells of unknown or undetermined aetiology that might constitute seizures\n* History of multiple seizures or diagnosis of epilepsy\n* Any progressive (e.g., neurodegenerative) neurological disorder such as multiple sclerosis or Parkinson's disease\n* Chronic uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)\n* Metallic objects\u002Fimplants (excluding dental fillings) unless cleared to be MRI compatible (i.e. MRI compatible joint replacement)\n* Any implants controlled by physiological signs in\u002Fnear the head\n\n  * Pacemaker\n  * Implanted medication pump\n  * Vagal nerve stimulator\n  * Deep brain stimulator or TENS unit\n  * Ventriculo-peritoneal shunt\n  * Cochlear implant\n* Impaired ability to sense heat\u002Fpain, open wounds etc.\n* Increased intracranial pressure\n* Intracranial lesion, from a known genetic disorder or from acquired neurologic disease (e.g. stroke, tumor, cerebral palsy, severe head injury, or significant dysmorphology).\n* History of head injury resulting in prolonged loss of consciousness (\\>15minutes) or neurological sequelae\n* Ongoing pregnancy and breastfeeding. All participants capable of becoming pregnant will be required to have active contraception; any participant who is pregnant or breastfeeding will not be enrolled in the study.\n\nOther exclusion criteria\n\n* Clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, cancer, pulmonary decompensation etc.)\n* Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, intellectual retardation, dementia, etc. of the subject\n* Having legal obligation for psychiatric treatment.\n* Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation.\n* Previous enrolment into the current investigation\n* Enrolment of the PI, his\u002Fher family members, employees and other dependent persons.","ALL","18 Years","65 Years",{"count":75,"type":76},70,"ESTIMATED","INTERVENTIONAL",[79],"NA","This project is a double blind randomized clinical trials that examines the efficacy of cerebellar non invasive stimulation for apathy improvement in patients with schizophrenia",[82],"Schizophrenia; Psychosis","2024-11-14",{"date":85,"type":86},"2024-11-19","ACTUAL",{"date":88,"type":86},"2024-04-15",{"date":90,"type":76},"2027-12-12",{"name":59,"class":6},2]