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Behavioural Intervention

fMRI Neurofeedback for Schizophrenia with Auditory Hallucinations

N/A
Recruiting
Led By margaret niznikiewicz
Research Sponsored by Harvard Medical School (HMS and HSDM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Auditory hallucinations not responsive to pharmacology as determined by chart review and a clinical interview of SCID.
Patients diagnosed with SZ or schizoaffective disorder using DSM-5 criteria
Must not have
Electroconvulsive therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-4 weeks post intervention

Summary

This trial found that neurofeedback may help to reduce auditory hallucinations in patients with schizophrenia who have not responded to medication.

Who is the study for?
This trial is for individuals with schizophrenia or schizoaffective disorder who experience auditory hallucinations that haven't improved with medication. They must be diagnosed using DSM-5 criteria and have a verbal IQ above 70. People cannot join if they've had major head trauma, neurological illness, electroconvulsive therapy, or substance abuse issues within the last five years.
What is being tested?
The study tests neurofeedback interventions targeting the superior temporal gyrus (STG) to manage activation and connectivity in the brain's default mode network (DMN), aiming to reduce auditory hallucinations in participants resistant to standard treatments.
What are the potential side effects?
As this trial involves non-invasive real-time fMRI neurofeedback without drugs, side effects may include discomfort from lying still during scans or possible anxiety from participation but no pharmacological side effects are expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My hearing voices are not getting better with medication.
Select...
I have been diagnosed with schizophrenia or schizoaffective disorder.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have undergone electroconvulsive therapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-4 weeks post intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-4 weeks post intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
percent change in the STG BOLD signal, post- relative to pre-NFB
Secondary study objectives
percent change in the MPFC-PCC connectivity measure, post- relative to pre-NFB.
reduction in scores on Psychotic Symptoms Rating Scale, post- relative to pre, NFB

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: stg-rt-fMRIExperimental Treatment1 Intervention
will receive feedback from the STG
Group II: sham-rt-fMRIPlacebo Group1 Intervention
will receive feedback from the motor cortex

Find a Location

Who is running the clinical trial?

Harvard Medical School (HMS and HSDM)Lead Sponsor
204 Previous Clinical Trials
1,316,581 Total Patients Enrolled
7 Trials studying Schizophrenia
726 Patients Enrolled for Schizophrenia
Northeastern UniversityOTHER
99 Previous Clinical Trials
70,972 Total Patients Enrolled
Boston VA Research Institute, Inc.Lead Sponsor
23 Previous Clinical Trials
10,742 Total Patients Enrolled
Mclean HospitalOTHER
217 Previous Clinical Trials
22,089 Total Patients Enrolled
20 Trials studying Schizophrenia
1,638 Patients Enrolled for Schizophrenia
Cambridge Health AllianceOTHER
62 Previous Clinical Trials
22,375 Total Patients Enrolled
2 Trials studying Schizophrenia
361 Patients Enrolled for Schizophrenia
margaret niznikiewiczPrincipal InvestigatorBoston VA Research Institute, Inc.

Media Library

stg-rt-fMRI-Neurofeeback (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05299749 — N/A
Schizophrenia Research Study Groups: stg-rt-fMRI, sham-rt-fMRI
Schizophrenia Clinical Trial 2023: stg-rt-fMRI-Neurofeeback Highlights & Side Effects. Trial Name: NCT05299749 — N/A
stg-rt-fMRI-Neurofeeback (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05299749 — N/A
~16 spots leftby Jun 2025
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