fMRI-based Neurofeedback to Relieve Drug-resistant Auditory Hallucinations

Not Applicable

Not yet recruiting

• Conditions: Hallucinations, Auditory; Schizophrenia; Hallucinations, Visual

• Registration Number: NCT04798131
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-14
• Study First Submitted QC: 2021-03-11
• Study First Posted: 2021-03-15
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-24
• Last Update Posted: 2022-03-25
• Study Start: 2022-12
• Primary Completion: 2026-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Change from baseline Questionnaire for Psychotic Experiences (QPE) measure for severity of hallucinations	1 month after treatment	QPE will be measured at t0 (randomization) and at 1 month after treatment
Changes in global functioning relative to baseline	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).
Changes in quality of life relative to baseline	1 month after treatment	SQLS score will be measured at t0 (randomization) and at 1 month after treatment
Changes in structural MRI markers relative to baseline	1 month after treatment	Gyrification Index will be measured at t0 (randomization) and at 1 month after treatment
Change from baseline Visual analogue scale (VAS) measure for severity of hallucinations	1 month after treatment	VAS will be measured at t0 (randomization) and at 1 month after treatment
Changes in functional MRI markers relative to baseline	1 month after treatment	Brain activity at rest and connectivity metrics will be measured at t0 (randomization) and at 1 month after treatment
Change from baseline Simplified Acute Physiology Score (SAPS) measure for severity of hallucinations	1 month after treatment	SAPS will be measured at t0 (randomization) and at 1 month after treatment
Change from baseline in Positive and Negative Syndrome Scale (PANSS) measure of hallucinations severity	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