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Rt-fMRI Neurofeedback and AH in Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03504579
Recruitment Status : Recruiting
First Posted : April 20, 2018
Last Update Posted : November 14, 2018
Information provided by (Responsible Party):
Margaret Niznikiewicz, Harvard Medical School

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.

Condition or disease Intervention/treatment Phase
Audio Visual Hallucinations Neurofeedback Schizophrenia Superior Temporal Gyrus Other: rt-fMRI neurofeedback Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: In the R61 phase of the study,changes in a target brain region(s) will be demonstrated after the rt-fMRI based neurofeedback session.
Masking: Double (Participant, Care Provider)
Primary Purpose: Other
Official Title: Real-time fMRI Feedback as a Tool to Mitigate Auditory Hallucinations in Schizophrenia
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

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

Primary Outcome Measures :
  1. rt-fMRI neurofeedback from STG [ Time Frame: 1-2 weeks, post rt-fMRI session ]
    changes in BOLD activation in STG

Secondary Outcome Measures :
  1. rt-fMRI neurofeedback from mPFC [ Time Frame: 1-2 weeks, post rt-fMRI session ]
    changes in BOLD activation in mPFC

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03504579

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Contact: Margaret Niznikiewicz, Ph.D. 617-653-4627
Contact: TBD TBD 617-000-0000

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United States, Massachusetts
Veterans Administration Health Care System Recruiting
Brockton, Massachusetts, United States, 02301
Contact: Caroline Decker, MA    774-826-1507   
Contact: Grace Francis, Ph.D.    774-826-1507   
Sub-Investigator: clemens Bauer, MD;Ph.D.         
Principal Investigator: Ann Shinn, MD         
Sponsors and Collaborators
Harvard Medical School
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Principal Investigator: margaret niznikiewicz, ph.d VA Boston Healthcare System
Principal Investigator: susan whitfield-Gabrieli, Ph.D. Massachusetts Institute of Technology

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Responsible Party: Margaret Niznikiewicz, associate professor; lab director, Harvard Medical School Identifier: NCT03504579    
Other Study ID Numbers: 7304878-01
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Margaret Niznikiewicz, Harvard Medical School:
auditory hallucinations
Additional relevant MeSH terms:
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Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms