fMRI-based Neurofeedback to Relieve Drug-resistant Auditory Hallucinations
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity Hospital, Lille
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Pregnancy
Contraindication to MRI scan
Claustrophobia
No social insurance
Trial design
Design model
Parallel
Treatments tested in this trial
Active neurofeedback procedure
Other interventionPatients 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 interventionPatients 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.
Treatment groups
84 Participants
are divided into 2 treatment groupsGroup A: ActiveExperimental treatment 1 intervention
Group B: ShamSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline in the Auditory Hallucination Rating Scale (AHRS) measure of hallucinations severity
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.
Time frame
1 month after treatmentSecondary outcomes
1
Change from baseline in Positive and Negative Syndrome Scale (PANSS) measure of hallucinations severity
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
Time frame
1 month after treatment2
Change from baseline Questionnaire for Psychotic Experiences (QPE) measure for severity of hallucinations
QPE will be measured at t0 (randomization) and at 1 month after treatment
Time frame
1 month after treatment3
Change from baseline Simplified Acute Physiology Score (SAPS) measure for severity of hallucinations
SAPS will be measured at t0 (randomization) and at 1 month after treatment
Time frame
1 month after treatment4
Change from baseline Visual analogue scale (VAS) measure for severity of hallucinations
VAS will be measured at t0 (randomization) and at 1 month after treatment
Time frame
1 month after treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Lille
Lead sponsor
National Research Agency, France
Collaborator
Source ClinicalTrials.gov