[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hallucinations-visual\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hallucinations-visual":48},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":5},"100423765",false,"NCT04798131","fMRI-based Neurofeedback to Relieve Drug-resistant Auditory Hallucinations","Treat Refractory Auditory Hallucinations in Schizophrenia Patients With fMRI-guided Neurofeedback: a Randomized-controlled Trial","INTRUDE","Inclusion Criteria:\n\n* Schizophrenia (according to the DSM-5 classification)\n* Frequent auditory hallucinations (SAPS item #1 ≥ 4)\n* Stable medication for at least 30 days\n* Absence of chronic neurological disorder (including seizure)\n* Able to provide free written consent to participate in the research\n\nExclusion Criteria:\n\n* Pregnancy\n* Contraindication to MRI scan\n* Claustrophobia\n* No social insurance","ALL","18 Years","60 Years",{"count":20,"type":21},84,"ESTIMATED","INTERVENTIONAL",[24],"NA","The INTRUDE trial aims at assessing the efficacy of an fMRI-based neurofeedback procedure on drug-resistant auditory hallucinations. Hallucinations are complex and transient mental states associated with subtle and brain-wide patterns of activity for which we were recently able to validate an fMRI multivariate decoder. Based on this progress, we can track patients' hallucinatory status using real-time fMRI. We will test whether schizophrenia patients with drug-resistant hallucinations can be trained to maintain the brain state associated with a no-hallucination condition using appropriate strategies and thus reduce overall severity. We will refer to a double-blind randomized placebo-controlled design. A total of 86 patients will be enrolled and equally split in an active neurofeedback group (n=43) and a sham group (n=43), matched for sex, age and PANSS scores. Each patient will benefit from 4 runs of either active or sham neurofeedback. The primary outcome measure will be the mean decrease of AHRS scores relative to baseline, and at 1 month post-treatment. We expect significant clinical benefits from fMRI-based neurofeedback on drug-resistant hallucinations compared with the sham group.",[27,28,29],"Schizophrenia","Hallucinations, Auditory","Hallucinations, Visual",[27,31,32,33,34,35],"Hallucinations","Drug-resistance","functional MRI","Neurofeedback","Machine-Learning.","RECRUITING","2026-05-14",{"date":39,"type":40},"2026-05-18","ACTUAL",{"date":42,"type":40},"2022-08-26",{"date":44,"type":21},"2026-07",{"name":46,"class":47},"University Hospital, Lille","OTHER",""]