The Neural Bases of Early Visual and Auditory Processing and Emotion Recognition Deficits in Schizophrenia

October 26, 2015 updated by: Shalvata Mental Health Center

Examining the Neural Bases of Early Visual and Auditory Processing and Emotion Recognition Deficits in Schizophrenia Using Magnetoencephalography

The purpose of this project is to examine potential mechanisms that may underlie early visual and auditory perception as well as visual and auditory affect perception deficits in schizophrenia and the possible connection between these processes. Given that affect perception largely involves visual and/or auditory information processing and likely relies on intact basic visual and/or auditory perceptual mechanisms, the investigators will examine affect perception deficits within the framework of the more basic visual and auditory processes. Specifically, the investigators will examine magnetophysiological correlates of vocal and visual affect discrimination, non-affective face discrimination and voice discrimination, and simple visual and auditory stimulus discrimination, using Magnetoencephalography (MEG), to identify neural mechanisms underlying perceptual deficits, as well as their contribution to affect perception deficits in schizophrenia.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients will be recruited from Shalvata mental health center and evaluated clinically in Shalvata mental health center. The MEG scan will take place at Bar-Ilan University at the Brain Research Center. Participants will get to and from the university with one of the researchers. Patients from the closed ward will be taken from Shalvata mental health center after receiving a signed letter from a relevant staff member allowing them to leave the hospital for the purpose of the research. At the end of the experiment hospitalized patients will be returned to the hospital and non-hospitalized ones to their preferred destination.

First stage (to take place in Shalvata): After the informed consent process a clinical evaluation will be performed. The evaluation will be administered to all participants and will include: demographic details and psychiatric history questionnaire, social functioning scale, handedness questionnaire, four-factor index of social statues for socioeconomic evaluation, Ischihara Color Blindness Test, Snellen wall chart for visual evaluation, TONI-3 test for intelligence evaluation, Hebrew version of the Manchester Short Assessment of Quality of Life, Interpersonal Reaction Index for empathy evaluation, and SCID for DSM-IV. In addition, the PANSS questionnaire will be administered to schizophrenic and schizoaffective patients. Time estimation: 1-2 hours.

Second stage (to take place at Bar-Ilan University and if necessary to be divided into two separate visits): Conducting a brain scan during a battery of tasks that will test neural mechanisms underlying visual and auditory perceptual deficits, as well as their contribution to affect perception deficits in schizophrenia at different levels of the visual and auditory processing. This stage will begin with a preparation for the scan (10-20 minutes) and then the following tasks will take place: Task 1. Gratings Perception task in which participants have to detect the 5% vertical gratings. The aim of this task is to identify the neural mechanisms underlying basic visual perceptual deficits in individuals with schizophrenia by probing the M- and P-pathways using HSF and LSF in a neutral, semantically meaningless, stimuli (~3 minutes); Task 2. Basic Color Processing Task - participants will have to detect 5% of white backgrounds among 180 red, green and gray backgrounds. The aim of this task is to asses neural mechanisms underlying basic visual perception by probing the M- and P pathways using basic color stimuli (~3minutes); Task 3. Orientation Detection Task - a task designed to identify another level of visual processing complexity, in which participants are asked to detect a missing gap in a square, displaying on green, red or gray background (~2 minutes); Task 4. Oddball Task in which participants have to detect infrequent sounds and ignore frequent and novel sounds. The aim of this task is to identify the basic neural mechanisms underlying auditory perception in individuals with schizophrenia (~13 minutes); Task 5. High and low spatial frequency facial expressions perception task. In this task participants have to identify the facial expression of the target stimuli out of three possible expressions: neutral facial expression, happy facial expression and afraid facial expression. The aim of this task is to identify the neural mechanisms underlying neutral facial perception deficit as well as affect perception deficit in individuals with schizophrenia by probing the M- and P-pathways using HSF and LSF facial stimuli (~25 minutes including breaks). Task 6. Colored Face Recognition task - Face stimuli are the same as the broad band stimuli from the previous task with one difference: faces are colored and surrounded by red, green or gray colored backgrounds. Procedure is the same as in the previous task (~25 minutes including breaks); Task 7. Processing of Affective Human Voices task in which participants have to detect and identify the content of human sounds (~15 minutes). Time estimation of the second stage of the experiment is about two hours including breaks. Total time estimation of both experimental stages: Four hours.

At the end of the experiment participants will be thanked and brought back to their destination (hospitalized participants will be returned to Shalvata Hospital). Participants will receive 200 NIS for transportation and time loss. Participants that will be screened out during the evaluation stage will receive 50 NIS for transportation and time loss.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Individuals diagnosed with schizophrenia

Description

Inclusion criteria for patients:

  • Capable and willing to provide informed consent
  • Diagnosis of schizophrenia or schizoaffective
  • Right handedness
  • Corrected visual acuity
  • No color blindness
  • Normal hearing
  • IQ ≥ 70

Inclusion Criteria for controls:

  • Capable and willing to provide informed consent
  • Right handedness
  • Corrected visual acuity
  • No color blindness
  • Normal hearing
  • IQ ≥ 70

Exclusion Criteria for patients:

  • Left handedness
  • Intellectual Disability
  • Impaired vision
  • Impaired hearing
  • Colour blindness
  • History of significant head injury or neurological illness
  • Current diagnosis of substance dependence
  • Metallic implants
  • Severe current mental instability that precludes participation in the MEG task

Exclusion Criteria for controls:

  • Psychiatric history
  • Intellectual Disability
  • Impaired vision
  • Impaired hearing
  • Colour blindness
  • History of significant head injury or neurological illness
  • Current diagnosis of substance dependence
  • Metallic implants

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Schizophrenia
Individuals with schizophrenia
Other: Magnetoencephalography
Magnetoencephalography is a non-invasive technique for investigating human brain activity. It allows the measurement of ongoing brain activity on a millisecond-by-millisecond basis, and it shows where in the brain activity is produced.
Other Names:
  • MEG
  • 4D-NeuroImage
Control
Neurotypical individuals
Other: Magnetoencephalography
Magnetoencephalography is a non-invasive technique for investigating human brain activity. It allows the measurement of ongoing brain activity on a millisecond-by-millisecond basis, and it shows where in the brain activity is produced.
Other Names:
  • MEG
  • 4D-NeuroImage

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Brain responses to early visual and auditory stimuli as measured by the MEG
Time Frame: Immediate
Amplitudes and brain sources of early auditory and visual components as measured by the MEG
Immediate

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Correlation between brain responses to early visual and auditory processing and brain patterns of affect perception
Time Frame: Immediate
Immediate
Correlation between brain responses to early visual and auditory processing and social functioning and quality of life questionnaire' grades
Time Frame: Immediate
Immediate

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shalvata Mental Health Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bar-Ilan University, Israel

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yuval Bloch, MD, Shalvata Mental Health Center

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 26, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 27, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 27, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0018-15-SHA

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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