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RecruitingNCT05299749Updated Sep 18, 2025

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

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.

Primary conditionSchizophrenia, Treatment-ResistantRegistry: SchizophreniaReclassifiedWhy we changed it
Registry
Schizophrenia — the first condition term the registry derived for this study.
ClinicalTrials.gg
Schizophrenia, Treatment-Resistant
Why
  1. The study's listed conditions name Schizophrenia, Treatment-Resistant, a narrower term within Schizophrenia.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Boston VA Research Institute, Inc. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as recruiting.
  • Started Mar 2022; still recruiting 4 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
104
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Schizophrenia
  • Auditory Hallucination
  • Treatment-resistant Schizophrenia

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Keywords

  • Auditory-Hallucination
  • Connectivity
  • brain-activity
  • default-mode-network
  • superior temporal gyrus
  • Neurofeedback
  • MRI
03

In context

Schizophrenia, Treatment-Resistant Reclassified

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 →

Lead sponsor

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 →

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
Terms in these criteria, in plain language(1)

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.

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
104 participants (estimated)

Study arms

  • Experimental
    stg-rt-fMRI

    will receive feedback from the STG

    Other: stg-rt-fMRI-Neurofeeback

  • Sham comparator
    sham-rt-fMRI

    will receive feedback from the motor cortex

    Other: sham-rt-fMRI-Neurofeedback

Interventions

  • Otherstg-rt-fMRI-Neurofeeback

    the patients will receive real-time feedback from the brain activity of the superior temporal gyrus

  • Othersham-rt-fMRI-Neurofeedback

    the patients will receive real-time feedback from the brain activity of the somato-motor cortex

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

07

Study locations

1 of 1 sites recruiting
  • Boston VA Healthcare System, Brockton
    Brockton, Massachusetts 02301, United States
    Recruiting
08

References and documents

Individual participant data

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

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05299749
Lead sponsor
Boston VA Research Institute, Inc.
Collaborators
Mclean Hospital, Northeastern University, Cambridge Health Alliance
Responsible party
Margaret Niznikiewicz (Professor in Psychiatry, Boston VA Research Institute, Inc.) — Principal investigator
First posted
Mar 29, 2022
Start date
Mar 1, 2022
Primary completion
Jun 30, 2026 (estimated)
Completion
Jun 30, 2026 (estimated)
Last update
Sep 18, 2025

Study contacts

margaret niznikiewicz, PhD
Contact
margaret_niznikiewicz@hms.harvard.edu
6176534627
Clemens Bauer, phd
Contact
c.bauer@northeastern.edu
617-870-1771
margaret niznikiewicz
principal investigator · Boston VA Research Institute, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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