Rt-fMRI Neurofeedback and AH in Schizophrenia

Real-time fMRI Feedback as a Tool to Mitigate Auditory Hallucinations in Schizophrenia

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Audio Visual Hallucinations; Neurofeedback; Superior Temporal Gyrus
• Intervention / Treatment: Other: rt-fMRI neurofeedback

Detailed Description

Auditory verbal hallucinations (AH) have long been a hallmark of schizophrenia (SZ) and are one of its major diagnostic features. They are difficult to manage with existing treatment options. Here, neurofeedback will be used to regulate the superior temporal gyrus (STG) activation which will not only lead to activation changes in the STG, but also to changes in the default mode network (DMN).

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.

The investigators will randomly assign 48 SZ patients to either SZ-intervention (n=24) or SZ-sham-rtfMRI (n=24). The STG targeted neurofeedback is predicted to bring changes in brain regions involved in AH (STG and DMN) in SZ-intervention group only. The R61 GO criterion will be BOLD signal reduction in the STG, and resting state connectivity reduction between MPFC-PCC, post rt-fMRI-feedback in SZ-intervention group.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Brockton, Massachusetts, United States, 02301
      • Veterans Administration Health Care System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: rt-fMRI neurofeedback aimed at STG; One session of rt-fMRI neurofeedback from the patient's STG.	Other: rt-fMRI neurofeedback; use of real time fMRI neurofeedback to achieve targeted brain changes
Sham Comparator: sham rt-fMRI; One session of rt-fMRI neurofeedback from the patient's motor cortex.	Other: rt-fMRI neurofeedback; use of real time fMRI neurofeedback to achieve targeted brain changes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rt-fMRI neurofeedback from STG	changes in BOLD activation in STG	1-2 weeks, post rt-fMRI session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rt-fMRI neurofeedback from mPFC	changes in BOLD activation in mPFC	1-2 weeks, post rt-fMRI session

Collaborators and Investigators

• Sponsor: Harvard Medical School (HMS and HSDM)
• Investigators: Principal Investigator: margaret niznikiewicz, ph.d, VA Boston Healthcare System; Principal Investigator: susan whitfield-Gabrieli, Ph.D., Massachusetts Institute of Technology

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): March 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: March 29, 2018
• First Submitted That Met QC Criteria: April 12, 2018
• First Posted (Actual): April 20, 2018

Study Record Updates

• Last Update Posted (Actual): November 29, 2022
• Last Update Submitted That Met QC Criteria: November 28, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: MRI; neurofeedback; schizophrenia; rt-fMRI; auditory hallucinations
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Schizophrenia Spectrum and Other Psychotic Disorders; Perceptual Disorders; Schizophrenia; Hallucinations
• Other Study ID Numbers: 7304878-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No