fMRI-based Neurofeedback to Relieve Drug-resistant Auditory Hallucinations (INTRUDE)

University Hospital, Lille

Status: Not yet enrolling

Conditions: Schizophrenia; Hallucinations, Visual; Hallucinations, Auditory

Treatments: Other: Sham neurofeedback procedure; Other: Active neurofeedback procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT04798131

2020_08

ANR-16-CE37-0015 (Other Identifier)

2020-A00631-38 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 84 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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84 participants in 2 patient groups

Active

Experimental group

Description:

The visual feedback will correspond to instructions, adapted to the current hallucinatory state and decoded online from the fMRI signal.

Treatment:

Other: Active neurofeedback procedure

Sham

Sham Comparator group

Description:

The visual feedback will correspond to random instructions independently of the fMRI signal.

Treatment:

Other: Sham neurofeedback procedure