Rt-fMRI Neurofeedback and AH in Schizophrenia

NCT03504579 | Completed DMC

• 1 other identifier: 7304878-01
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Auditory hallucinations in schizophrenia are one of the major symptoms of this disease and a major source of psychological discomfort. They are often difficult or impossible to treat with existing methods. This study will test the use of real-time fMRI neurofeedback to mitigate auditory verbal hallucinations in patients whose hallucinations are resistant to medication. Half of the patients will receive real time fMRI neurofeedback from a brain region involved in auditory hallucinations and half will receive it from motor cortex.

Conditions

Audio Visual Hallucinations; Neurofeedback; Schizophrenia; Superior Temporal Gyrus

Keywords

rt-fMRI; MRI; schizophrenia; auditory hallucinations; neurofeedback

Outcome Measures

Primary Outcomes (1)

• rt-fMRI neurofeedback from STG

  changes in BOLD activation in STG

  1-2 weeks, post rt-fMRI session

Secondary Outcomes (1)

• rt-fMRI neurofeedback from mPFC

  1-2 weeks, post rt-fMRI session

Study Arms (2)

rt-fMRI neurofeedback aimed at STG

EXPERIMENTAL

One session of rt-fMRI neurofeedback from the patient's STG.

Other: rt-fMRI neurofeedback

sham rt-fMRI

SHAM COMPARATOR

One session of rt-fMRI neurofeedback from the patient's motor cortex.

Other: rt-fMRI neurofeedback

Interventions

rt-fMRI neurofeedback OTHER

use of real time fMRI neurofeedback to achieve targeted brain changes

rt-fMRI neurofeedback aimed at STG; sham rt-fMRI

Eligibility Criteria

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

You may qualify if:

• a diagnosis of schizophrenia or schizoaffective disorder based on SCID interview (DSM-5) and
• the presence of auditory hallucinations (PANSS, item 3, score ≥4) with frequency of AH being at least once daily;
• age between 18-55 years;
• estimated IQ of above 80 as measured by WASI;
• English as the primary language;
• right-handed as determined by the Edinburgh Handedness Inventory (scoring + 60; Oldfield, 1971);
• an ability and desire to participate in the testing program as explained by an experimenter and confirmed with a written consent form.

You may not qualify if:

• history of ECT for the last 5 years;
• history of neurological illness or a traumatic head injury, defined as loss of consciousness for more than 5 minutes and/or structural sequelae following head trauma;
• history of severe or moderate alcohol (AUD) or substance use disorder (SUD) in the past five years, or mild AUD or SUD within the last year, according to DSM-5;
• the use, in the preceding year of steroids or barbiturates, which can affect cognitive function;
• hearing, vision or upper body impairment
• alcohol use in the last 24 hours;

Sponsors & Collaborators

• Harvard Medical School (HMS and HSDM): lead

Study Sites (1)

Veterans Administration Health Care System

Brockton, Massachusetts, 02301, United States

Location

Related Publications (2)

• Zhang J, Tusuzian E, Morfini F, Bauer CCC, Stone L, Awad A, Shinn AK, Niznikiewicz MA, Whitfield-Gabrieli S. Brain Structural and Functional Neuroimaging Features are Associated With Improved Auditory Hallucinations in Patients With Schizophrenia After Real-Time fMRI Neurofeedback. Depress Anxiety. 2025 Apr 8;2025:2848929. doi: 10.1155/da/2848929. eCollection 2025.

  PMID: 40236821 DERIVED

• Morfini F, Bauer CCC, Zhang J, Whitfield-Gabrieli S, Shinn AK, Niznikiewicz MA. Targeting the superior temporal gyrus with real-time fMRI neurofeedback: A pilot study of the indirect effects on self-referential processes in schizophrenia. Schizophr Res. 2024 Aug;270:358-365. doi: 10.1016/j.schres.2024.06.036. Epub 2024 Jul 4.

  PMID: 38968807 DERIVED

MeSH Terms

Conditions

Schizophrenia; Hallucinations

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, ph.d

  VA Boston Healthcare System

  PRINCIPAL INVESTIGATOR

• susan whitfield-Gabrieli, Ph.D.

  Massachusetts Institute of Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor; lab director

Model Details: In the R61 phase of the study,changes in a target brain region(s) will be demonstrated after the rt-fMRI based neurofeedback session.

Study Record Dates

• First Submitted: March 29, 2018
• First Posted: April 20, 2018
• Study Start: March 1, 2018
• Primary Completion: March 30, 2022
• Study Completion: June 30, 2022
• Last Updated: November 29, 2022

Record last verified: 2022-11

Locations

US (1)