NCT04798131Recruiting
fMRI-based Neurofeedback to Relieve Drug-resistant Auditory Hallucinations
Treat Refractory Auditory Hallucinations in Schizophrenia Patients With fMRI-guided Neurofeedback: a Randomized-controlled Trial
Source: ClinicalTrials.gov · Last updated 1 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 84 (estimated)
- First submitted
- 14 Jan 2021
- Start date
- 26 Aug 2022
- Primary completion date
- 30 Nov 2028
- Lead sponsor
- University Hospital, Lille
- Diseases
- Schizophrenia
- NCT number
- NCT04798131
What you commit to
- Study type: Interventional
- Planned participants: 84
- From 26 Aug 2022 to the primary completion date, 30 Nov 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Clinical condition incompatible with the study protocol (e.g. agitation, severe disorganization, catatonia)
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hop Fontan Chu Coordinator of this site? Confirm its status | Lille | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.