Neurofeedback treatment for schizophrenia patients with auditory hallucinations
Real-time fMRI Neurofeedback as a Tool to Mitigate Auditory Hallucinations in Patients With Schizophrenia - R33 Phase
This study is testing if a special brain training method can help people with schizophrenia who hear voices feel better by changing how their brain works.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 104 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Boston VA Research Institute, Inc. Academic / other |
| Locations | 1 site (Brockton, Massachusetts) |
| Trial ID | NCT05299749 on ClinicalTrials.gov |
What this trial studies
This intervention focuses on using real-time fMRI neurofeedback to help patients with schizophrenia who experience treatment-resistant auditory hallucinations. The study aims to regulate brain activity in the superior temporal gyrus (STG) and improve connectivity within the default mode network (DMN). Participants will be randomly assigned to either the neurofeedback group, which receives feedback from the STG, or a sham group, which receives feedback from the motor cortex. The study will involve five sessions of neurofeedback or sham treatment, with the goal of reducing auditory hallucinations and correlating brain changes with clinical improvements.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with schizophrenia or schizoaffective disorder who experience auditory hallucinations that are not responsive to pharmacological treatments.
Not a fit: Patients with neurological illnesses, major head trauma, or those who have undergone electroconvulsive therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel treatment option for patients with schizophrenia who do not respond to traditional medications.
How similar studies have performed: While neurofeedback approaches have been explored in other contexts, this specific application for treatment-resistant auditory hallucinations in schizophrenia is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Brockton, Massachusetts
- Boston VA Healthcare System, Brockton — Brockton, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: margaret niznikiewicz — Boston VA Research Institute, Inc.
- Study coordinator: margaret niznikiewicz, PhD
- Email: margaret_niznikiewicz@hms.harvard.edu
- Phone: 6176534627
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.