[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100573013":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":40,"responsibleParty":57,"collaborators":26,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":26,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":42,"whyStopped":26,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Hannover Medical School","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"iTBS","EXPERIMENTAL","Active intermittent theta-burst stimulation of the cerebellar vermis and the left dorsolateral prefrontal cortex",[13],"Device: Intermittent theta-burst stimulation",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham iTBS","SHAM_COMPARATOR","Sham intermittent theta-burst stimulation of the cerebellar vermis and the left dorsolateral prefrontal cortex",[19],"Device: Sham intermittent theta-burst stimulation",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Intermittent theta-burst stimulation","Intermittent theta-burst stimulation, applied sequentially to the cerebellar vermis and the left dorsolateral prefrontal cortex",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Sham intermittent theta-burst stimulation","Sham intermittent theta-burst stimulation, applied sequentially to the cerebellar vermis and the left dorsolateral prefrontal cortex",[15],[32],{"name":33,"affiliation":5,"role":34},"Rasmus Schülke, MD (Dr. med.)","PRINCIPAL_INVESTIGATOR",[36],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","+49 511 532 2039","schuelke.rasmus@mh-hannover.de",[41],{"facility":5,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"RECRUITING","Hanover","Lower Saxony","30625","Germany","DE",{"type":49,"coordinates":50},"Point",[51,52],9.73322,52.37052,{"lat":52,"lon":51},[55,56],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},{"name":33,"role":34,"phone":26,"phoneExt":26,"email":26},{"type":34,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Schülke, Rasmus Dr.","Principal Investigator","100573013","intermittent-theta-burst-stimulation-to-improve-negative-symptoms-and-cognition-in-schizophrenia-100573013",false,"NCT06740747","Intermittent Theta-Burst Stimulation to Improve Negative Symptoms and Cognition in Schizophrenia","Intermittierende Theta-Burst-Stimulation Zur Verbesserung Von Negativsymptomatik Und Kognition Bei Schizophrenie","ITBS-NKS-2024","Inclusion Criteria:\n\n* Diagnosis of schizophrenia (ICD-10: F20.-)\n* Age: 18-65 years\n* Ability to give informed consent\n* Signed informed consent form\n\nExclusion Criteria:\n\n* Any electronic implants\n* Non-MRI-compatible metal implants (e.g., pacemaker, cochlear implant, insulin pump, metal fragment injuries, work in the metal-processing industry)\n* Non-TMS-compatible metal implants (compatible items include: earrings, piercings, dental fillings, crowns, implants)\n* Claustrophobia\n* Epilepsy\n* History of traumatic brain injury within the last 3 months\n* History of stroke\n* Active central nervous system (CNS) infection\n* History of CNS infection within the last 3 months\n* Pregnancy\n* Current drug, medication, or alcohol abuse\n* Simultaneous participation in another clinical trial\n* Planned changes in psychopharmacological medication within the next 2 weeks\n* Severe physical illnesses that could endanger the patient, affect the examinations or make the MRI scanning cause additional burden","ALL","18 Years","65 Years",{"count":72,"type":73},60,"ESTIMATED","INTERVENTIONAL",[76],"NA","The planned randomized, sham-controlled, double-blind, monocentric study aims to evaluate the effectiveness of intermittent Theta-Burst Stimulation (iTBS) on negative symptoms and cognitive deficits in schizophrenia. Both the cerebellar vermis and the left dorsolateral prefrontal cortex will be stimulated successively within the same session.\n\nThe goal of this trial is to learn if intermittent theta-burst stimulation (iTBS) of the cerebellum and the left dorsolateral prefrontal cortext (DLPFC) can treat negative symptoms and improve cognition in patients with schizophrenia. The main question it aims to answer is:\n\nDoes iTBS of the cerebellum and the left DLPFC improve negative symptoms in patients with schizophrenia? Researchers will compare iTBS to sham stimulation to see if iTBS improves negative symptoms.\n\nParticipants will:\n\n* Receive 10 sessions of iTBS over the course of 2 weeks\n* Undergo extensive examination before iTBS treatment, immediately after iTBS treatment and 4 weeks after iTBS treatment. The examination includes assessment of negative symptoms; psychometric assessment of cognition, social cognition, depressive symptoms; functional magnetic resonance imaging; assessment of eye movements; blood and saliva sampling; assessment of adverse events and stimulation associated sensations.\n\nThe study thus seeks to determine whether iTBS of the fronto-cerebellar network might improve negative symptoms and cognition by altering the network's functional activity. Additionally, it will investigate whether a pro-inflammatory cytokine profile could affect iTBS outcomes and whether inflammatory markers could be affected by iTBS.",[79],"Schizophrenia Patients",[9,81,82,83,84],"intermittent theta-burst stimulation","negative symptoms","cognition","schizophrenia","2025-07-16",{"date":87,"type":88},"2025-07-20","ACTUAL",{"date":90,"type":88},"2025-04-08",{"date":92,"type":73},"2026-12-31",{"name":5,"class":6},1]