Health TrialsbyHealthPanel

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

ConditionsSchizophreniaAuditory HallucinationTreatment-resistant Schizophrenia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorBoston VA Research Institute, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

neurologic illness

major head trauma

electroconvulsive therapy

alcohol or drug dependence

Trial design

Design model

Parallel

Treatments tested in this trial

  • stg-rt-fMRI-Neurofeeback

    Other intervention

    the patients will receive real-time feedback from the brain activity of the superior temporal gyrus

  • sham-rt-fMRI-Neurofeedback

    Other intervention

    the patients will receive real-time feedback from the brain activity of the somato-motor cortex

Treatment groups

104 Participants
are divided into 2 treatment groups
Group A: stg-rt-fMRIExperimental treatment 1 intervention
Group B: sham-rt-fMRISham comparator 1 intervention

Trial outcomes

Primary outcomes

1

percent change in the STG BOLD signal, post- relative to pre-NFB

does real-time fMRI neurofidback reduce BOLD activity in STG, post NFB

Time frame
0-4 weeks post intervention

Secondary outcomes

1

reduction in scores on Psychotic Symptoms Rating Scale, post- relative to pre, NFB

does real-time fMRI neurofidback reduce auditory hallucinations, post NFB

Time frame
0-4 weeks post intervention
2

percent change in the MPFC-PCC connectivity measure, post- relative to pre-NFB.

Does real time NFB reduce connectivity in MPFC-PCC, post NFB

Time frame
0-4 weeks post intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Boston VA Research Institute, Inc.

Lead sponsor

Mclean Hospital

Collaborator

Northeastern University

Collaborator

Cambridge Health Alliance

Collaborator

Source ClinicalTrials.gov
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