Rt-fMRI Neurofeedback and AH in Schizophrenia

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03504579
• Other study ID #: 7304878-01
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: June 30, 2022

Study information

• Verified date: November 2022
• Source: Harvard Medical School (HMS and HSDM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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;

Related Conditions & MeSH terms

• Audio Visual Hallucinations
• Hallucinations
• Neurofeedback
• Schizophrenia
• Superior Temporal Gyrus

Intervention

Other:
• rt-fMRI neurofeedback
use of real time fMRI neurofeedback to achieve targeted brain changes

Locations

Country	Name	City	State
United States	Veterans Administration Health Care System	Brockton	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Harvard Medical School (HMS and HSDM)

Country where clinical trial is conducted

United States, 

Outcome

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