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Behavioural Intervention

fMRI Neurofeedback for Schizophrenia with Auditory Hallucinations

N/A
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-4 weeks post intervention
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
My hearing voices are not getting better with medication.
Select...
I have been diagnosed with schizophrenia or schizoaffective disorder.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
percent change in the STG BOLD signal, post- relative to pre-NFB
Secondary outcome measures
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
195 Previous Clinical Trials
1,315,941 Total Patients Enrolled
7 Trials studying Schizophrenia
726 Patients Enrolled for Schizophrenia
Northeastern UniversityOTHER
88 Previous Clinical Trials
61,206 Total Patients Enrolled
Boston VA Research Institute, Inc.Lead Sponsor
22 Previous Clinical Trials
10,702 Total Patients Enrolled

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any remaining vacancies to join this clinical trial?

"Affirmative. The study, which was uploaded on the first day of March 2022 and modified for the last time in September 2020, is now searching for 104 individuals at 1 medical facility according to clinicaltrials.gov's records."

Answered by AI

Does this study accept participants who are at least twenty years old?

"This research trial is restricted to individuals between 18 and 55 years old. There are 47 studies available for minors, while 169 exist for those over the age of 65."

Answered by AI

What is the upper ceiling of participants allowed in this clinical trial?

"Affirmative, the information found on clinicaltrials.gov states that this trial is currently seeking out participants. First posted to the site on March 1st 2022 and recently updated September 20th 2022, it requires 104 individuals from one medical centre."

Answered by AI

Am I eligible to be included in this research study?

"The study is accepting 104 patients with schizophrenia from ages 18 to 55 years old. Notably, participants must meet the following conditions: having a DSM-5 diagnosis of SZ or schizoaffective disorder, exhibiting auditory hallucinations that are resistant to pharmacotherapy as proven through both chart reviews and SCID interviews."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
What site did they apply to?
Boston VA Healthcare System, Brockton
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2

What questions have other patients asked about this trial?

How much do it pay?
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Real-time fMRI Neurofeedback in Patients With Schizophrenia and Auditory Hallucinations
Margaret Niznikiewicz 2022. "Real-time fMRI Neurofeedback in Patients With Schizophrenia and Auditory Hallucinations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05299749.
All > Schizophrenia
~8 spots leftby Jun 2024
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