[{"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":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":5},"100423765","fmri-based-neurofeedback-to-relieve-drug-resistant-auditory-hallucinations-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":21,"type":22},84,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29,30],"Schizophrenia","Hallucinations, Auditory","Hallucinations, Visual",[28,32,33,34,35,36],"Hallucinations","Drug-resistance","functional MRI","Neurofeedback","Machine-Learning.","RECRUITING","2026-05-14",{"date":40,"type":41},"2026-05-18","ACTUAL",{"date":43,"type":41},"2022-08-26",{"date":45,"type":22},"2026-07",{"name":47,"class":48},"University Hospital, Lille","OTHER"]