NCT04798131 fMRI-based Neurofeedback to Relieve Drug-resistant Auditory Hallucinations
| NCT ID | NCT04798131 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Lille |
| Condition | Schizophrenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 84 participants |
| Start Date | 2022-08-26 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 84 participants in total. It began in 2022-08-26 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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: * Pregnancy * Contraindication to MRI scan * Claustrophobia * No social insurance
Contact & Investigator
Renaud JARDRI, MD,PhD
PRINCIPAL INVESTIGATOR
University Hospital, Lille
Frequently Asked Questions
Who can join the NCT04798131 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Schizophrenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04798131 currently recruiting?
Yes, NCT04798131 is actively recruiting participants. Contact the research team at renaud.jardri@chru-lille.fr for enrollment information.
Where is the NCT04798131 trial being conducted?
This trial is being conducted at Lille, France.
Who is sponsoring the NCT04798131 clinical trial?
NCT04798131 is sponsored by University Hospital, Lille. The principal investigator is Renaud JARDRI, MD,PhD at University Hospital, Lille. The trial plans to enroll 84 participants.
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