Real-time fMRI Neurofeedback in Patients With Schizophrenia and Auditory Hallucinations

Schizophrenia Clinical Trial

Official title:

Real-time fMRI Neurofeedback as a Tool to Mitigate Auditory Hallucinations in Patients With Schizophrenia - R33 Phase

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05299749
• Other study ID #: 4R33MH113751-03
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: September 2022
• Source: Boston VA Research Institute, Inc.
• Contact: Margaret Niznikiewicz, PhD
• Phone: 617-855-2570
• Email: lstone[@]mclean.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Neurofeedback intervention aimed to regulate the superior temporal gyrus (STG) activation and default mode network (DMN) connectivity as well as to reduce the auditory hallucinations (AH) schizophrenia patients with medication resistant AH.

Description:

Here, the investigators propose that neurofeedback aimed to regulate the superior temporal gyrus (STG) activation will not only lead to activation changes in the STG, but also to changes in the default mode network (DMN), as well as to reductions in AH, and that the brain and clinical changes will be correlated. The theoretical framework for the current proposal is an AH model that assumes that AH result from abnormalities in a network of regions including STG, and medial prefrontal cortex (MPFC) and posterior cingulate cortex (PCC), the two latter regions are core medial hubs of DMN that are related to self-referential processing. This model is supported by several theoretical papers and experimental evidence well as preliminary data by the investigators (PD). In both R61 and R33 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. This R33 phase will consist of an SZ-intervention group (random n=52) that will receive 5 sessions of rt-fMRI feedback targeting STG, while SZ-sham group (random n=52) will receive 5 sham-rt-fMRI sessions. Based on our R61 phase data, the investigators predict that rt-fMRI feedback aimed at STG will reduce AH which will be, in turn, associated with reductions in the STG activation and in the DMN connectivity (i.e., brain changes achieved in R61 and replicated in R33) in SZ- intervention group only. Five sessions of rt-fMRI feedback will address the question of dose response at brain and clinical levels. The impact of rt-fMRI neurofeedback and of sham-rt-fMRI on AH (primary outcome), and on delusions, negative symptoms and working memory (WM) (exploratory outcome) will be assessed with clinical and neuropsychological measures. In an exploratory aim, based on the existing literature, the investigators predict the improvement in delusions, negative symptoms and in WM score, only post-rt-fMRI neurofeedback targeting the STG and not post-sham-rt-fMRI.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• patients diagnosed with SZ or schizoaffective disorder using DSM-5 criteria
• auditory hallucinations not responsive to pharmacology as determined by chart review and a clinical interview of SCID.

Exclusion Criteria:

• neurologic illness
• major head trauma
• electroconvulsive therapy
• alcohol or drug dependence
• alcohol or drug abuse within the past five years
• verbal IQ below 70

Related Conditions & MeSH terms

• Auditory Hallucination
• Hallucinations
• Schizophrenia
• Treatment-resistant Schizophrenia

Intervention

Other:
• stg-rt-fMRI-Neurofeeback
the patients will receive real-time feedback from the brain activity of the superior temporal gyrus
• sham-rt-fMRI-Neurofeedback
the patients will receive real-time feedback from the brain activity of the somato-motor cortex

Locations

Country	Name	City	State
United States	Boston VA Healthcare System, Brockton	Brockton	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Boston VA Research Institute, Inc.	Cambridge Health Alliance, Mclean Hospital, Northeastern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percent change in the STG BOLD signal, post- relative to pre-NFB	does real-time fMRI neurofidback reduce BOLD activity in STG, post NFB	0-4 weeks post intervention
Secondary	reduction in scores on Psychotic Symptoms Rating Scale, post- relative to pre, NFB	does real-time fMRI neurofidback reduce auditory hallucinations, post NFB	0-4 weeks post intervention
Secondary	percent change in the MPFC-PCC connectivity measure, post- relative to pre-NFB.	Does real time NFB reduce connectivity in MPFC-PCC, post NFB	0-4 weeks post intervention