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fMRI-based Neurofeedback to Relieve Drug-resistant Auditory Hallucinations

RecruitingNAAges 18 Years - 60 YearsAllUniversity Hospital, Lille
NCT04798131 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 f

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📋 Eligibility rules (as published)
Inclusion Criteria: * Right-handed female/male between 18 to 60 y.o. * Schizophrenia (according to the DSM-5 classification) * Frequent auditory hallucinations (SAPS item #1 ≥ 4) * Stable medication for at least 30 days * Absence of chronic neurological disorder (including seizure) * Able to provide free written consent to participate in the research Exclusion Criteria: * Refusal to participate after clear and honest information about the study has been provided * Clinical condition incompatible with the study protocol (e.g. agitation, severe disorganization, catatonia) * Pregnancy * Contraindication to MRI scan: pacemaker, ferromagnetic vascular clip, ferromagnetic foreign body * Morphological criteria: weight \>130kg, abdominal cirumference exceeding magnet aperture, shoulder width * Claustrophobia * Refusal to be informed of any incidental findings observed during the MRNI * No social insurance
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What it tests

  • Active neurofeedback procedure
  • Sham neurofeedback procedure
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Where

1 site
Hop Fontan Chu
Lille, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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