Recruiting

Neurofeedback

Sponsor:

Boston VA Research Institute, Inc.

Code:

NCT05299749

Conditions

Schizophrenia

Auditory Hallucination

Treatment-resistant Schizophrenia

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

stg-rt-fMRI-Neurofeeback

sham-rt-fMRI-Neurofeedback

Study Details

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

Study ID

NCT05299749

Start date

Mar 1, 2022

Status verified date

Sep, 2025

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

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

Enrollment

104 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: stg-rt-fMRI

will receive feedback from the STG

sham comparator: sham-rt-fMRI

will receive feedback from the motor cortex

Interventions

stg-rt-fMRI-Neurofeeback

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

sham-rt-fMRI-Neurofeedback

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

Primary outcome measure

  • percent change in the STG BOLD signal, post- relative to pre-NFB [ Time Frame: 0-4 weeks post intervention ]

Central Contacts and Locations

Central contacts

margaret niznikiewicz, PhD

6176534627margaret_niznikiewicz@hms.harvard.edu

Clemens Bauer, phd

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

Locations

Boston VA Healthcare System, Brockton

Recruiting

Brockton, Massachusetts, United States, 02301

Contacts

Mia Kriksciun, BA

774 826 1507mia.kriksciun@va.gov

More Information

Sponsor

Boston VA Research Institute, Inc.

Last update posted

Sep 18, 2025

Last verified

Sep, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston VA Research Institute, Inc. on 2025-09-18.