Clinical trial NCT04798131: fMRI-based Neurofeedback to Relieve Drug-resistant Auditory Hallucinations
Official title: Treat Refractory Auditory Hallucinations in Schizophrenia Patients With fMRI-guided Neurofeedback: a Randomized-controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Schizophrenia
Hallucinations, Auditory
Hallucinations, Visual
Keywords: Schizophrenia
Hallucinations
Drug-resistance
functional MRI
Neurofeedback
Machine-Learning.
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: National Research Agency, France
First posted: 2021-03-15
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Primary outcomes:
measure: Change from baseline in the Auditory Hallucination Rating Scale (AHRS) measure of hallucinations severity
timeFrame: 1 month after treatment
Secondary outcomes:
measure: Change from baseline in Positive and Negative Syndrome Scale (PANSS) measure of hallucinations severity
timeFrame: 1 month after treatment
measure: Change from baseline Questionnaire for Psychotic Experiences (QPE) measure for severity of hallucinations
timeFrame: 1 month after treatment
measure: Change from baseline Simplified Acute Physiology Score (SAPS) measure for severity of hallucinations
timeFrame: 1 month after treatment
measure: Change from baseline Visual analogue scale (VAS) measure for severity of hallucinations
timeFrame: 1 month after treatment
measure: Changes in global functioning relative to baseline
timeFrame: 1 month after treatment
measure: Changes in quality of life relative to baseline
timeFrame: 1 month after treatment
measure: Changes in structural MRI markers relative to baseline
timeFrame: 1 month after treatment
measure: Changes in structural MRI markers relative to baseline
timeFrame: 1 month after treatment
measure: Changes in functional MRI markers relative to baseline
timeFrame: 1 month after treatment
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Lille
name: Renaud JARDRI, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: