fMRI-based Neurofeedback to Relieve Drug-resistant Auditory Hallucinations

Schizophrenia Clinical Trial

— INTRUDE  

Official title:

Treat Refractory Auditory Hallucinations in Schizophrenia Patients With fMRI-guided Neurofeedback: a Randomized-controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04798131
• Other study ID #: 2020_08
• Secondary ID: 2020-A00631-38AN
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2022
• Est. completion date: July 2026

Study information

• Verified date: March 2022
• Source: University Hospital, Lille
• Contact: Renaud JARDRI, MD,PhD
• Phone: 0320445962
• Email: renaud.jardri[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 84
• Est. completion date: July 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Hallucinations
• Hallucinations, Auditory
• Hallucinations, Visual
• Schizophrenia

Intervention

Other:
• Active 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.
• Sham 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	National Research Agency, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 month after treatment
Secondary	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	1 month after treatment
Secondary	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	1 month after treatment
Secondary	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	1 month after treatment
Secondary	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	1 month after treatment
Secondary	Changes in global functioning relative to baseline	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).	1 month after treatment
Secondary	Changes in quality of life relative to baseline	SQLS score will be measured at t0 (randomization) and at 1 month after treatment	1 month after treatment
Secondary	Changes in structural MRI markers relative to baseline	Cortical thickness will be measured at t0 (randomization) and at 1 month after treatment	1 month after treatment
Secondary	Changes in structural MRI markers relative to baseline	Gyrification Index will be measured at t0 (randomization) and at 1 month after treatment	1 month after treatment
Secondary	Changes in functional MRI markers relative to baseline	Brain activity at rest and connectivity metrics will be measured at t0 (randomization) and at 1 month after treatment	1 month after treatment