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Trial record 37 of 491 for:    Harvard

Rt-fMRI Neurofeedback and AH in Schizophrenia

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ClinicalTrials.gov Identifier: NCT03504579
Recruitment Status : Not yet recruiting
First Posted : April 20, 2018
Last Update Posted : April 23, 2018
Sponsor:
Information provided by (Responsible Party):
Margaret Niznikiewicz, Harvard Medical School

Brief Summary:
Auditory hallucinations in schizophrenia are one of the major symptoms of this disease and a major source of psychological discomfort. They are often difficult or impossible to treat with existing methods. This study will test the use of real-time fMRI neurofeedback to mitigate auditory verbal hallucinations in patients whose hallucinations are resistant to medication. Half of the patients will receive real time fMRI neurofeedback from a brain region involved in auditory hallucinations and half will receive it from motor cortex.

Condition or disease Intervention/treatment Phase
Audio Visual Hallucinations Neurofeedback Schizophrenia Superior Temporal Gyrus Other: rt-fMRI neurofeedback Not Applicable

Detailed Description:

Auditory verbal hallucinations (AH) have long been a hallmark of schizophrenia (SZ) and are one of its major diagnostic features. They are difficult to manage with existing treatment options. Here, neurofeedback will be used to regulate the superior temporal gyrus (STG) activation which will not only lead to activation changes in the STG, but also to changes in the default mode network (DMN).

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.

The investigators will randomly assign 48 SZ patients to either SZ-intervention (n=24) or SZ-sham-rtfMRI (n=24). The STG targeted neurofeedback is predicted to bring changes in brain regions involved in AH (STG and DMN) in SZ-intervention group only. The R61 GO criterion will be BOLD signal reduction in the STG, and resting state connectivity reduction between MPFC-PCC, post rt-fMRI-feedback in SZ-intervention group.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: In the R61 phase of the study,changes in a target brain region(s) will be demonstrated after the rt-fMRI based neurofeedback session.
Masking: Double (Participant, Care Provider)
Primary Purpose: Other
Official Title: Real-time fMRI Feedback as a Tool to Mitigate Auditory Hallucinations in Schizophrenia
Estimated Study Start Date : July 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: rt-fMRI neurofeedback aimed at STG
One session of rt-fMRI neurofeedback from the patient's STG.
Other: rt-fMRI neurofeedback
use of real time fMRI neurofeedback to achieve targeted brain changes

Sham Comparator: sham rt-fMRI
One session of rt-fMRI neurofeedback from the patient's motor cortex.
Other: rt-fMRI neurofeedback
use of real time fMRI neurofeedback to achieve targeted brain changes




Primary Outcome Measures :
  1. rt-fMRI neurofeedback from STG [ Time Frame: 1-2 weeks, post rt-fMRI session ]
    changes in BOLD activation in STG


Secondary Outcome Measures :
  1. rt-fMRI neurofeedback from mPFC [ Time Frame: 1-2 weeks, post rt-fMRI session ]
    changes in BOLD activation in mPFC



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • a diagnosis of schizophrenia or schizoaffective disorder based on SCID interview (DSM-5) and
  • the presence of auditory hallucinations (PANSS, item 3, score ≥4) with frequency of AH being at least once daily;
  • age between 18-55 years;
  • estimated IQ of above 80 as measured by WASI;
  • English as the primary language;
  • right-handed as determined by the Edinburgh Handedness Inventory (scoring + 60; Oldfield, 1971);
  • an ability and desire to participate in the testing program as explained by an experimenter and confirmed with a written consent form.

Exclusion Criteria:

  • history of ECT for the last 5 years;
  • history of neurological illness or a traumatic head injury, defined as loss of consciousness for more than 5 minutes and/or structural sequelae following head trauma;
  • history of severe or moderate alcohol (AUD) or substance use disorder (SUD) in the past five years, or mild AUD or SUD within the last year, according to DSM-5;
  • the use, in the preceding year of steroids or barbiturates, which can affect cognitive function;
  • hearing, vision or upper body impairment
  • alcohol use in the last 24 hours;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03504579


Contacts
Contact: TBD TBD 617-111-1111 TBD1@hms.harvard.edu
Contact: TBD TBD 617-000-0000 TBD2@hms.harvard.edu

Sponsors and Collaborators
Harvard Medical School
Investigators
Principal Investigator: margaret niznikiewicz, ph.d VA Boston Healthcare System
Principal Investigator: susan whitfield-Gabrieli, Ph.D. Massachusetts Institute of Technology

Responsible Party: Margaret Niznikiewicz, associate professor; lab director, Harvard Medical School
ClinicalTrials.gov Identifier: NCT03504579     History of Changes
Other Study ID Numbers: 7304878-01
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Margaret Niznikiewicz, Harvard Medical School:
rt-fMRI
MRI
schizophrenia
auditory hallucinations
neurofeedback

Additional relevant MeSH terms:
Schizophrenia
Hallucinations
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms