Brain Imaging, Attention, and Auditory Processing in Schizophrenia

November 28, 2018 updated by: Judith Ford, San Francisco Veterans Affairs Medical Center

Predictive Coding Abnormalities in Psychosis: EEG and fMRI

This is a research study designed to examine how the psychiatric illness called schizophrenia affects brain function and thinking abilities such as attention and memory during simple computer-based tasks, and how measures of brain function are related to performance. The investigators do this by looking at brain activity using electroencephalography (EEG) and magnetic resonance imaging (MRI). The investigators compare participants' results to the activity in their brain as well as clinical measures and questionnaires also completed during this study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  • EEG recording: In this procedure, the researcher will assess the participant's brain function while performing simple computer-based tasks. The computer tasks involve presentation of pictures or sounds to which the participant responds by pressing a button. The investigators will also record some of the participant's own speech sounds and play them back to them. The participant will be given clear instructions and a chance to practice before each task. While you are performing these tasks, the investigator will record the weak electrical signals produced by your brain, or "brain waves", using a technique called electroencephalography (EEG). In order to record the participant's EEG, sensors (small plastic discs) will be attached to specific locations on their scalp. The participant's scalp will be gently scrubbed before the sensors are attached. The sensors are held in place on the scalp using a nylon cap that fits snugly on the head. Sensors will also be attached above and below the participant's eyes and will record their eye movements. It will take approximately one hour to attach the sensors. The entire EEG will take approximately 2-3 hours. Before taking part in the EEG session, please make sure to wash hair and scalp. Do not use conditioner or a 2-in-1 shampoo/conditioner. The participant's hair should be dry before arrival. The investigators ask this in order to make the set-up process go more smoothly.

    • During some tasks, participants will feel a vibratory sensation that is produced with an electrical current and it is possible that it may feel like a slight shock. The current is controlled and cannot reach levels that are painful or dangerous. Every participant experiences this sensation differently, so it is important that participants tell the researchers if the sensation becomes uncomfortable to you so the current can be adjusted or the task can be stopped.
    • Participants may be asked to complete additional EEGs for this study, depending on your interest in participating and your availability. All EEG sessions will last approximately 2 hrs.

  • MRI: In the fMRI procedure, we will use a magnet to measure blood flow to participants' brains while they do different tasks. Participants will be asked to lie down on a platform that can be slid into the middle of the magnet. A plastic MRI imaging coil will be placed around participants' heads. You will not come into contact with the coil during the experiment. Foam pads will be placed around the participant's head to limit head movement during the experiment. The investigators will then slide you into the magnet. At different points during the experiment, participants will be asked to do the same tasks they did in the training session prior to the scan. During the scan, participants will be asked to either lie still and rest, or do some tasks like tapping their fingers, remembering letters or digits, or viewing images that are designed to activate different parts of the brain. The entire MRI will take approximately two hours.

    • While performing the MRI, participants may be asked to wear a cap that contains multiple EEG sensors applied to your scalp. A removable gel will be used. The EEG measures electrical activity produced by the brain while participants undergo the MRI. Set up for the EEG will take approximately 30 to 60 minutes.
    • Participants may be asked to repeat an MRI session if the data the study team collects is not usable due to data quality issues, or if the participant is unable to stay awake in the magnet during your scan.
  • Brief interview session: There will be a series of questions about participants' education, smoking status, and economic background. Participants will also be given a list of words to read to the researcher. If the participant is a patient diagnosed with one of the above-mentioned psychiatric disorders, they will be asked to participate in an additional interview, lasting about one hour, focusing on how they have been feeling recently.
  • Behavioral testing: In this part, the participant will use a touch screen computer, mouse and/or paper and pencil to perform certain visual and auditory tests of your mental abilities. Specifically, these tests will assess participants' memory, attention, language, and motor skills. This testing will last approximately one hour. Depending on the participant's preference, this testing can be done on the same day as an EEG or on a different day. The order of the two sessions does not matter, so long as they occur within one week of each other.

Additional Information:

  • If information about a participant's mental health is needed from their current or former doctor(s), they will be asked to sign a separate permission form before the researcher can contact their doctor(s).

Study Type

Observational

Enrollment (Actual)

202

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94121
        • San Francisco VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who have been diagnosed with schizophrenia and meet our research criteria of symptoms indicative of a diagnosis of schizophrenia within their lifetime are eligible for this study.

Healthy controls who have never met criteria for a psychiatric disorder and meet our research criteria will also be included in this study.

Description

Inclusion Criteria:

  • The subject population will include 18 to 75 year old participants of any gender, race, and ethnicity. All subjects will be able to speak and understand English.

Schizophrenia subjects:

1. Patients must be diagnosed with DSM-IV schizophrenia, schizophreniform, or schizoaffective disorder based on a SCID-P interview.

Comparison subjects:

1. Control participants must not have past or present Axis I diagnosis as determined by the SCID-NP.

Exclusion Criteria:

  • All subjects:

    1. A hearing deficit greater than 40dB in both ears detected during the hearing test
    2. Substance dependence, as per clinical judgment, in the past 1 year (except caffeine and nicotine)
    3. A history of significant medical/neurological disease such as cardiac, thyroid, renal, hepatic or neurological
    4. History of head injury with loss of consciousness greater than 15 minutes
    5. Any other condition or medication, which in the opinion of the investigator would preclude participation in the study.
    6. Non-English speaking.

Comparison subjects:

1. Any first-degree relative with schizophrenia or bipolar disorder.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with Schizophrenia
Individuals who have been previously diagnosed with schizophrenia and meet our research criteria for symptoms indicative of schizophrenia within their lifetime.
Diagnostic test: Electroencephalography (EEG) and Magnetic Resonance Imaging (MRI)
The investigators will use these techniques combined with attention tests, memory tests, and clinical interviews to explore connections between these measures and activity in the brain in patients with a diagnosis of schizophrenia and healthy controls.
Healthy Controls
Individuals who have not met criteria for a psychiatric disorder within their lifetime according to our research criteria for symptoms indicative of a psychiatric disorder.
Diagnostic test: Electroencephalography (EEG) and Magnetic Resonance Imaging (MRI)
The investigators will use these techniques combined with attention tests, memory tests, and clinical interviews to explore connections between these measures and activity in the brain in patients with a diagnosis of schizophrenia and healthy controls.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EEG
Time Frame: Day 1
Electroencephalography, measures signals from the brain while participants conduct specific tasks that measure memory and attention.
Day 1
MRI
Time Frame: Day 1
Magnetic Resonance Imaging, measures activity in, and takes detailed pictures of the brain while participants conduct specific tasks that measure memory and attention.
Day 1
Memory and Attention tasks
Time Frame: Day 1
Tasks involve saying words, pressing buttons at specific times, listening, and viewing pictures.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

San Francisco Veterans Affairs Medical Center

Investigators

  • Principal Investigator: Judith Ford, PhD, San Francisco VA Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2014

Primary Completion (Actual)

May 11, 2018

Study Completion (Actual)

May 11, 2018

Study Registration Dates

First Submitted

February 27, 2017

First Submitted That Met QC Criteria

February 27, 2017

First Posted (Actual)

March 3, 2017

Study Record Updates

Last Update Posted (Actual)

November 30, 2018

Last Update Submitted That Met QC Criteria

November 28, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MH058262

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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