Hallucinations, Auditory, Hallucinations, Visual, Schizophrenia
Conditions
Keywords
Schizophrenia, Hallucinations, Drug-resistance, functional MRI, Neurofeedback, Machine-Learning.
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.
Interventions
OTHERActive 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.
OTHERSham 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.
Sponsors
University Hospital, Lille
National Research Agency, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 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 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 | Cortical thickness 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 |
Countries
France
Contacts
CONTACTRenaud JARDRI, MD,PhD
PRINCIPAL_INVESTIGATORRenaud JARDRI, MD,PhD
University Hospital, Lille
Outcome results
None listed