fMRI-based Neurofeedback to Relieve Drug-resistant Auditory Hallucinations

NCT04798131 | Not Yet Recruiting

• 3 other identifiers: 2020_082020-A00631-38ANR-16-CE37-0015
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Schizophrenia; Hallucinations, Auditory; Hallucinations, Visual

Keywords

Schizophrenia; Hallucinations; Drug-resistance; functional MRI; Neurofeedback; Machine-Learning.

Outcome Measures

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.

  1 month after treatment

Secondary Outcomes (9)

• Change from baseline in Positive and Negative Syndrome Scale (PANSS) measure of hallucinations severity

  1 month after treatment

• Change from baseline Questionnaire for Psychotic Experiences (QPE) measure for severity of hallucinations

  1 month after treatment

• Change from baseline Simplified Acute Physiology Score (SAPS) measure for severity of hallucinations

  1 month after treatment

• Change from baseline Visual analogue scale (VAS) measure for severity of hallucinations

  1 month after treatment

• Changes in global functioning relative to baseline

  1 month after treatment

Study Arms (2)

Active

EXPERIMENTAL

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

Other: Active neurofeedback procedure

Sham

SHAM COMPARATOR

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

Other: Sham neurofeedback procedure

Interventions

Active neurofeedback procedure OTHER

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.

Active

Sham neurofeedback procedure OTHER

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.

Sham

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy
• Contraindication to MRI scan
• Claustrophobia
• No social insurance

Sponsors & Collaborators

• University Hospital, Lille: lead
• National Research Agency, France: collaborator

MeSH Terms

Conditions

Schizophrenia; Hallucinations

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Renaud JARDRI, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Renaud JARDRI, MD,PhD

CONTACT

0320445962; renaud.jardri@chru-lille.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: March 15, 2021
• Study Start: December 1, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 25, 2022

Record last verified: 2022-03