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Rt-fMRI Neurofeedback and AH in Schizophrenia

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03504579
Enrollment
25
Registered
2018-04-20
Start date
2018-03-01
Completion date
2022-06-30
Last updated
2022-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Audio Visual Hallucinations, Neurofeedback, Schizophrenia, Superior Temporal Gyrus

Keywords

rt-fMRI, MRI, schizophrenia, auditory hallucinations, neurofeedback

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.

Interventions

OTHERrt-fMRI neurofeedback

use of real time fMRI neurofeedback to achieve targeted brain changes

Sponsors

Harvard Medical School (HMS and HSDM)
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Caregiver)

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
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;

Design outcomes

Primary

MeasureTime frameDescription
rt-fMRI neurofeedback from STG1-2 weeks, post rt-fMRI sessionchanges in BOLD activation in STG

Secondary

MeasureTime frameDescription
rt-fMRI neurofeedback from mPFC1-2 weeks, post rt-fMRI sessionchanges in BOLD activation in mPFC

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026