Schizophrenia Clinical Trial
Official title:
Real-time fMRI Feedback as a Tool to Mitigate Auditory Hallucinations in Schizophrenia
NCT number | NCT03504579 |
Other study ID # | 7304878-01 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 1, 2018 |
Est. completion date | June 30, 2022 |
Verified date | November 2022 |
Source | Harvard Medical School (HMS and HSDM) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | June 30, 2022 |
Est. primary completion date | March 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | 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; |
Country | Name | City | State |
---|---|---|---|
United States | Veterans Administration Health Care System | Brockton | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Harvard Medical School (HMS and HSDM) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | rt-fMRI neurofeedback from STG | changes in BOLD activation in STG | 1-2 weeks, post rt-fMRI session | |
Secondary | rt-fMRI neurofeedback from mPFC | changes in BOLD activation in mPFC | 1-2 weeks, post rt-fMRI session |
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