Brain Scan Feedback Training for Drug-resistant Hallucinations in Schizophrenia
Tests brain-scan neurofeedback against a sham procedure in adults with schizophrenia and hallucinations.
Plain-language title generated from the registry record
Registry title: fMRI-based Neurofeedback to Relieve Drug-resistant Auditory Hallucinations
Key facts
- Where
- Lille, FranceSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 60 years old?
Source: NCT04798131, who can take part
Where in France
- Hop Fontan ChuLille, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital, Lille
- Trial code
- NCT04798131
- Record updated
- 1 October 2026
- Original 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.Read full original descriptionShow less
Treat Refractory Auditory Hallucinations in Schizophrenia Patients With fMRI-guided Neurofeedback: a Randomized-controlled Trial
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.
Inclusion: 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: Clinical condition incompatible with the study protocol (e.g. agitation, severe disorganization, catatonia); Refusal to participate after clear and honest information about the study has been provided; 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.