Rt-fMRI Neurofeedback and AH in Schizophrenia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2022-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Audio Visual Hallucinations Neurofeedback Schizophrenia Superior Temporal Gyrus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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rt-fMRI neurofeedback aimed at STG

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

Group Type EXPERIMENTAL

rt-fMRI neurofeedback

Intervention Type OTHER

use of real time fMRI neurofeedback to achieve targeted brain changes

sham rt-fMRI

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

Group Type SHAM_COMPARATOR

rt-fMRI neurofeedback

Intervention Type OTHER

use of real time fMRI neurofeedback to achieve targeted brain changes

Interventions

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rt-fMRI neurofeedback

use of real time fMRI neurofeedback to achieve targeted brain changes

Intervention Type OTHER

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No