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NCT Number: NCT04798131

fMRI-based Neurofeedback to Relieve Drug-resistant Auditory Hallucinations

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.

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Key information

Conditions

Schizophrenia Hallucinations Hallucinations, Auditory Hallucinations, Visual Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Schizophrenia Spectrum and Other Psychotic Disorders Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hop Fontan Chu

Lille, France

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active neurofeedback procedure

Other

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.

Sham neurofeedback procedure

Other

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 outcomes

  1. Change from baseline in the Auditory Hallucination Rating Scale (AHRS) measure of hallucinations severity

    Time frame: 1 month after treatment

    AHRS will be measured at t0 (randomization) and at 1 month after treatment Minimum score is 2, maximum score is 41, higher score indicates more severe symptoms.

Secondary outcomes

  1. Change from baseline in Positive and Negative Syndrome Scale (PANSS) measure of hallucinations severity

    Time frame: 1 month after treatment

    PANSS will be measured at t0 (randomization) and at 1 month after treatment The PANSS contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. rate from 1 to 7 on each symptom scale. The total score is the sum of all scales with a minimum score of 30 and a maximum score of 210

  2. Change from baseline Questionnaire for Psychotic Experiences (QPE) measure for severity of hallucinations

    Time frame: 1 month after treatment

    QPE will be measured at t0 (randomization) and at 1 month after treatment

  3. Change from baseline Simplified Acute Physiology Score (SAPS) measure for severity of hallucinations

    Time frame: 1 month after treatment

    SAPS will be measured at t0 (randomization) and at 1 month after treatment

  4. Change from baseline Visual analogue scale (VAS) measure for severity of hallucinations

    Time frame: 1 month after treatment

    VAS will be measured at t0 (randomization) and at 1 month after treatment

  5. Changes in global functioning relative to baseline

    Time frame: 1 month after treatment

    Global Assessment of Functioning (GAF) is a numeric scale be measured at t0 (randomization) and at 1 month after treatment Scores range from 100 (extremely high functioning) to 1 (severely impaired).

  6. Changes in quality of life relative to baseline

    Time frame: 1 month after treatment

    SQLS score will be measured at t0 (randomization) and at 1 month after treatment

  7. Changes in structural MRI markers relative to baseline

    Time frame: 1 month after treatment

    Cortical thickness will be measured at t0 (randomization) and at 1 month after treatment

  8. Changes in structural MRI markers relative to baseline

    Time frame: 1 month after treatment

    Gyrification Index will be measured at t0 (randomization) and at 1 month after treatment

  9. Changes in functional MRI markers relative to baseline

    Time frame: 1 month after treatment

    Brain activity at rest and connectivity metrics will be measured at t0 (randomization) and at 1 month after treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Renaud JARDRI, MD,PhD

CONTACT

[email protected]

0320445962 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • National Research Agency, France

Registry information

Official study title

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

Acronym: INTRUDE

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 15, 2021
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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