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Clinical Trials/NCT03504579
NCT03504579
Completed
Not Applicable

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

Harvard Medical School (HMS and HSDM)1 site in 1 country25 target enrollmentMarch 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Audio Visual Hallucinations
Sponsor
Harvard Medical School (HMS and HSDM)
Enrollment
25
Locations
1
Primary Endpoint
rt-fMRI neurofeedback from STG
Status
Completed
Last Updated
3 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2018
End Date
June 30, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Harvard Medical School (HMS and HSDM)
Responsible Party
Principal Investigator
Principal Investigator

Margaret Niznikiewicz

associate professor; lab director

Harvard Medical School (HMS and HSDM)

Eligibility Criteria

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;

Outcomes

Primary Outcomes

rt-fMRI neurofeedback from STG

Time Frame: 1-2 weeks, post rt-fMRI session

changes in BOLD activation in STG

Secondary Outcomes

  • rt-fMRI neurofeedback from mPFC(1-2 weeks, post rt-fMRI session)

Study Sites (1)

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