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Recruiting NCT04798131

fMRI-based Neurofeedback to Relieve Drug-resistant Auditory Hallucinations

No phase Interventional Schizophrenia Hallucinations, Auditory Hallucinations, Visual

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Active neurofeedback procedure, Sham neurofeedback procedure.
Who it may be relevant to
Registry conditions: Schizophrenia, Hallucinations, Auditory, Hallucinations, Visual. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Treat Refractory Auditory Hallucinations in Schizophrenia Patients With fMRI-guided Neurofeedback: a Randomized-controlled Trial

Overview

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.

Interventions

  • Other Active neurofeedback procedure
    Patients will perform 5 fMRI sessions. Four consecutive fMRI runs (1/ day) during which they will continuously receive visual feedback computed from the fMRI signal analyzed with the hallucinations decoder. Patients will be trained to maintain the brain state associated with the no-hallucination state using appropriate coping strategies. A 5th fMRI scan will be performed at 1 month post-treatment.
  • Other Sham neurofeedback procedure
    Patients will perform 5 fMRI sessions. Four consecutive fMRI runs (1/ day) during which they will receive a random feedback and a 5th run at 1 month post-treatment.

Primary outcome measures

  • Change from baseline in the Auditory Hallucination Rating Scale (AHRS) measure of hallucinations severity [Time frame: 1 month after treatment]
Secondary outcome measures (9)
  • Change from baseline in Positive and Negative Syndrome Scale (PANSS) measure of hallucinations severity [Time frame: 1 month after treatment]
  • Change from baseline Questionnaire for Psychotic Experiences (QPE) measure for severity of hallucinations [Time frame: 1 month after treatment]
  • Change from baseline Simplified Acute Physiology Score (SAPS) measure for severity of hallucinations [Time frame: 1 month after treatment]
  • Change from baseline Visual analogue scale (VAS) measure for severity of hallucinations [Time frame: 1 month after treatment]
  • Changes in global functioning relative to baseline [Time frame: 1 month after treatment]
  • Changes in quality of life relative to baseline [Time frame: 1 month after treatment]
  • Changes in structural MRI markers relative to baseline [Time frame: 1 month after treatment]
  • Changes in structural MRI markers relative to baseline [Time frame: 1 month after treatment]
  • Changes in functional MRI markers relative to baseline [Time frame: 1 month after treatment]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

France · 1 center
  • Hop Fontan Chu — Lille

Identifiers

NCT: NCT04798131 · 2020_08 · 2020-A00631-38 · ANR-16-CE37-0015

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗