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fMRI-based Neurofeedback to Relieve Drug-resistant Auditory Hallucinations

Sponsor: University Hospital, Lille • ClinicalTrials.gov ID: NCT04798131

Registry updated: 2026-10-01

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Description

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 12 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 and re-evaluated at 2 months post-treatment. We expect significant clinical benefits from fMRI-based neurofeedback on drug-resistant hallucinations compared with the sham group.

Interventions

Active neurofeedback procedure (Other)
Patients will perform 3 fMRI sessions. After one baseline fMRI run, two consecutive fMRI sessions (1/ day) during which they will continuously receive visual feedback (12 runs in total) computed from the fMRI signal analyzed with the hallucinations decoder. Patients will be trained to maintain the brain state associated with the no-hallucination state using appropriate coping strategies. Two post-treatment visits are scheduled at 1 and 2 months to assess hallucinations severity.
Sham neurofeedback procedure (Other)
Patients will perform 3 fMRI sessions. After one baseline fMRI run, two consecutive fMRI sessions (1/ day) during which they will receive a random feedback (12 runs in total). Two post-treatment visits are scheduled at 1 and 2 months with the same clinical assessment than the active group.

Eligibility criteria

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

Conditions

Schizophrenia Hallucinations, Auditory Hallucinations, Visual

Locations

Hop Fontan Chu — Lille, France

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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