An interventional study of stg-rt-fMRI-Neurofeeback and sham-rt-fMRI-Neurofeedback in Schizophrenia, Auditory Hallucination and Treatment-resistant Schizophrenia, sponsored by Boston VA Research Institute, Inc.. Recruiting at 1 site in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2025-09-18.
Sponsored by Boston VA Research Institute, Inc. · Not applicable, Interventional, and Treatment
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.
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.
53 studies on the registry are indexed under Schizophrenia, Treatment-Resistant; 22 are open to participants now.
This study's planned enrollment of 104 is above the median of 60 across 46 interventional studies indexed under Schizophrenia, Treatment-Resistant.
Browse Schizophrenia, Treatment-Resistant studies →Boston VA Research Institute, Inc. is the lead sponsor of 20 studies on the registry; 4 are open to participants now.
Compared within Schizophrenia, Treatment-Resistant, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Schizophrenia. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
will receive feedback from the STG
Other: stg-rt-fMRI-Neurofeeback
will receive feedback from the motor cortex
Other: sham-rt-fMRI-Neurofeedback
the patients will receive real-time feedback from the brain activity of the superior temporal gyrus
the patients will receive real-time feedback from the brain activity of the somato-motor cortex
percent change in the STG BOLD signal, post- relative to pre-NFB
does real-time fMRI neurofidback reduce BOLD activity in STG, post NFB
Time frame: 0-4 weeks post intervention
reduction in scores on Psychotic Symptoms Rating Scale, post- relative to pre, NFB
does real-time fMRI neurofidback reduce auditory hallucinations, post NFB
Time frame: 0-4 weeks post intervention
percent change in the MPFC-PCC connectivity measure, post- relative to pre-NFB.
Does real time NFB reduce connectivity in MPFC-PCC, post NFB
Time frame: 0-4 weeks post intervention
Plan to share: Yes — The Clinical, Cognitive and Imaging data will be made publicly available
Supporting information: Study protocol, Statistical analysis plan
Time frame: after results are published in peer reviewed journal; in perpetuity
Access criteria: researchers as confirmed by NIMH
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Schizophrenia, Treatment-Resistant →
Boston VA Research Institute, Inc.