fMRI-based Neurofeedback to Relieve Drug-resistant Auditory Hallucinations

Condition(s) studied

Investigational drug(s) / intervention(s)

Active neurofeedback procedure: Patients will perform 3 fMRI sessions. After one baseline fMRI run, two consecutive fMRI sessions (1/ day) during which they will continuously receive visual feedback (12 runs in total) 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. Two post-treatment visits are scheduled at 1 and 2 months to assess hallucinations severity.

Sham neurofeedback procedure: Patients will perform 3 fMRI sessions. After one baseline fMRI run, two consecutive fMRI sessions (1/ day) during which they will receive a random feedback (12 runs in total). Two post-treatment visits are scheduled at 1 and 2 months with the same clinical assessment than the active group.

Study 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 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.

Eligibility

Primary outcome measure(s)

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

Trial sites (1)

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