fMRI-based brain training to help reduce drug-resistant auditory hallucinations

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial will enroll 86 adults with schizophrenia and drug-resistant auditory hallucinations, randomly assigning them to active real-time fMRI neurofeedback or a sham control. Participants undergo 12 neurofeedback sessions aimed at maintaining a brain activity pattern linked to no hallucinations, guided by a validated fMRI decoder. Outcomes will compare changes in hallucination severity between groups in a double-blind, placebo-controlled design. The study uses stable medication status and ensures safety through MRI contraindication screening and monitoring. Primary results will focus on the average change in hallucination-related brain and clinical measures.

Why it matters

Who can join: the full rules

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

Where it's running

• Hop Fontan Chu
  Lille, France Recruiting

Study contacts

• Principal investigator: Renaud JARDRI, MD,PhD — University Hospital, Lille
• Study coordinator: Renaud JARDRI, MD,PhD
• Email: renaud.jardri@chru-lille.fr
• Phone: 0320445962

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.