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

NCT05299749 | Recruiting

• 1 other identifier: 4R33MH113751-03
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Auditory Hallucination; Treatment-resistant Schizophrenia

Keywords

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

Outcome Measures

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

  0-4 weeks post intervention

Secondary Outcomes (2)

• reduction in scores on Psychotic Symptoms Rating Scale, post- relative to pre, NFB

  0-4 weeks post intervention

• percent change in the MPFC-PCC connectivity measure, post- relative to pre-NFB.

  0-4 weeks post intervention

Study Arms (2)

stg-rt-fMRI

EXPERIMENTAL

will receive feedback from the STG

Other: stg-rt-fMRI-Neurofeeback

sham-rt-fMRI

SHAM COMPARATOR

will receive feedback from the motor cortex

Other: sham-rt-fMRI-Neurofeedback

Interventions

stg-rt-fMRI-Neurofeeback OTHER

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

stg-rt-fMRI

sham-rt-fMRI-Neurofeedback OTHER

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

sham-rt-fMRI

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Boston VA Research Institute, Inc.: lead
• Mclean Hospital: collaborator
• Northeastern University: collaborator
• Cambridge Health Alliance: collaborator

Study Sites (1)

Boston VA Healthcare System, Brockton

Brockton, Massachusetts, 02301, United States

RECRUITING

MeSH Terms

Conditions

Schizophrenia; Hallucinations; Schizophrenia, Treatment-Resistant

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

• margaret niznikiewicz

  Boston VA Research Institute, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

margaret niznikiewicz, PhD

CONTACT

6176534627; margaret_niznikiewicz@hms.harvard.edu

Clemens Bauer, phd

CONTACT

617-870-1771; c.bauer@northeastern.edu

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: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Psychiatry

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: March 29, 2022
• Study Start: March 1, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: after results are published in peer reviewed journal; in perpetuity
• Access Criteria: researchers as confirmed by NIMH

Locations

US (1)