Clinical trial NCT03504579: Rt-fMRI Neurofeedback and AH in Schizophrenia
Official title: Real-time fMRI Feedback as a Tool to Mitigate Auditory Hallucinations in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Audio Visual Hallucinations
Neurofeedback
Schizophrenia
Superior Temporal Gyrus
Keywords: rt-fMRI
MRI
schizophrenia
auditory hallucinations
neurofeedback
Lead sponsor: Harvard Medical School (HMS and HSDM)
Sponsor class: OTHER
First posted: 2018-04-20
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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.

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;

Primary outcomes:
measure: rt-fMRI neurofeedback from STG
timeFrame: 1-2 weeks, post rt-fMRI session
Secondary outcomes:
measure: rt-fMRI neurofeedback from mPFC
timeFrame: 1-2 weeks, post rt-fMRI session
Other outcomes:
Locations:
city: Brockton
country: United States
facility: Veterans Administration Health Care System
state: Massachusetts
Study officials:
affiliation: VA Boston Healthcare System
name: margaret niznikiewicz, ph.d
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts Institute of Technology
name: susan whitfield-Gabrieli, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: