Real-time fMRI Neurofeedback in Patients With Schizophrenia and Auditory Hallucinations

Not Applicable

Recruiting

• Conditions: Auditory Hallucination; Treatment-resistant Schizophrenia; Schizophrenia
• Interventions: Other: sham-rt-fMRI-Neurofeedback; Other: stg-rt-fMRI-Neurofeeback

• Registration Number: NCT05299749
• Lead Sponsor: Boston VA Research Institute, Inc.

Brief Summary

Neurofeedback intervention aimed to regulate the superior temporal gyrus (STG) activation and default mode network (DMN) connectivity as well as to reduce the auditory hallucinations (AH) schizophrenia patients with medication resistant AH.

Detailed Description

Here, the investigators propose that neurofeedback aimed to regulate the superior temporal gyrus (STG) activation will not only lead to activation changes in the STG, but also to changes in the default mode network (DMN), as well as to reductions in AH, and that the brain and clinical changes will be correlated. The theoretical framework for the current proposal is an AH model that assumes that AH result from abnormalities in a network of regions including STG, and medial prefrontal cortex (MPFC) and posterior cingulate cortex (PCC), the two latter regions are core medial hubs of DMN that are related to self-referential processing. This model is supported by several theoretical papers and experimental evidence well as preliminary data by the investigators (PD). In both R61 and R33 the investigators will study SZ patients with medication resistant AH in the rt-fMRI intervention arm and in the sham-rt-fMRI arm. In both arms, the task and the rt-fMRI session structure will be identical. The SZ-intervention group will receive feedback from the STG while SZ-sham group will receive feedback from the motor cortex. In addition, 2 functional fMRI tasks will examine the effect of rt-fMRI neurofeedback and of sham-rt-fMRI on brain response. This R33 phase will consist of an SZ-intervention group (random n=52) that will receive 5 sessions of rt-fMRI feedback targeting STG, while SZ-sham group (random n=52) will receive 5 sham-rt-fMRI sessions. Based on our R61 phase data, the investigators predict that rt-fMRI feedback aimed at STG will reduce AH which will be, in turn, associated with reductions in the STG activation and in the DMN connectivity (i.e., brain changes achieved in R61 and replicated in R33) in SZ- intervention group only. Five sessions of rt-fMRI feedback will address the question of dose response at brain and clinical levels. The impact of rt-fMRI neurofeedback and of sham-rt-fMRI on AH (primary outcome), and on delusions, negative symptoms and working memory (WM) (exploratory outcome) will be assessed with clinical and neuropsychological measures. In an exploratory aim, based on the existing literature, the investigators predict the improvement in delusions, negative symptoms and in WM score, only post-rt-fMRI neurofeedback targeting the STG and not post-sham-rt-fMRI.

Study Timeline

• Study Start: 2022-03-01
• Study First Submitted: 2022-03-08
• Study First Submitted QC: 2022-03-24
• Study First Posted: 2022-03-29
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-17
• Last Update Posted: 2024-05-20
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

• patients diagnosed with SZ or schizoaffective disorder using DSM-5 criteria
• auditory hallucinations not responsive to pharmacology as determined by chart review and a clinical interview of SCID.

Exclusion Criteria

• neurologic illness
• major head trauma
• electroconvulsive therapy
• alcohol or drug dependence
• alcohol or drug abuse within the past five years
• verbal IQ below 70

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sham-rt-fMRI	sham-rt-fMRI-Neurofeedback	will receive feedback from the motor cortex
stg-rt-fMRI	stg-rt-fMRI-Neurofeeback	will receive feedback from the STG

Primary Outcome Measures

Name	Time	Method
percent change in the STG BOLD signal, post- relative to pre-NFB	0-4 weeks post intervention	does real-time fMRI neurofidback reduce BOLD activity in STG, post NFB

Secondary Outcome Measures

Name	Time	Method
percent change in the MPFC-PCC connectivity measure, post- relative to pre-NFB.	0-4 weeks post intervention	Does real time NFB reduce connectivity in MPFC-PCC, post NFB
reduction in scores on Psychotic Symptoms Rating Scale, post- relative to pre, NFB	0-4 weeks post intervention	does real-time fMRI neurofidback reduce auditory hallucinations, post NFB

Trial Locations

Locations (1)

Boston VA Healthcare System, Brockton; 🇺🇸 Brockton, Massachusetts, United States