Changes in Brain Synchronization During Perceptual and Linguistic Tasks in Schizophrenic Patients

March 7, 2012 updated by: Shalvata Mental Health Center

This study aims to identify electrophysiological correlates of impaired perceptual and linguistic processes in chronic schizophrenic patients, un-medicated first-episode schizophrenic patients and their healthy relatives.

Following administrating some questionnaires (demographic details and psychiatric history questionnaire, handedness questionnaire, reading abilities test and positive and negative symptoms questionnaire) and performing a perception test and a verbal abstract intelligence test, participants will conduct a brain scan during a series of perceptual and linguistic tasks.

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.

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.
150

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.

Study Locations

  • Israel
      • Hod-Hasharon, Israel
        • Shalvata MHC

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

  1. Chronic patients - Up to 30 chronic schizophrenic patients.
  2. Naive patients - Up to 30 unmedicated first episode schizophrenic patients.
  3. Patients' relatives - Up to 60 family members (parents or siblings) of the participants - control group 1.
  4. Students - Up to 30 students from Bar-Ilan University - control group 2.

Description

Inclusion Criteria:

Inclusion criteria for chronic patients:

  • Hebrew native speakers.
  • Diagnosis of schizophrenia with a history of more than one episode.
  • Capable and willing to provide informed consent.

Inclusion criteria for naive patients:

  • Hebrew native speakers.
  • Diagnosis of schizophrenia with a history of only one episode and unmedicated.
  • Capable and willing to provide informed consent.

Inclusion criteria for patients' relatives (control group 1):

  • Hebrew native speakers.
  • Without any psychiatric history.
  • Have a child and/or a sibling with schizophrenia.

Inclusion Criteria for students (control group 2):

  • Hebrew native speakers.
  • Without any psychiatric history.

Exclusion Criteria:

Exclusion Criteria for patient groups (chronic and "naïve"):

  • Left handedness.
  • Reading disability.
  • Visual perception disability.
  • Brain damage and/or a history of seizures.
  • Impaired intelligence.
  • Metal implants.

Exclusion Criteria for control groups (family members and students):

  • Psychiatric history.
  • Left handedness.
  • Reading disability.
  • Visual perception disability.
  • Brain damage and/or a history of seizures.
  • Impaired intelligence.
  • Metal 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.
Students
Healthy students from Bar-Ilan University
Device: Magnetoencephalograph (MEG)
Conducting a brain scan during a series of perceptual and linguistic tasks
Schizophrenic patients' relatives
Healthy family members (parents or siblings) of the schizophrenic participants (chronic and naive)
Device: Magnetoencephalograph (MEG)
Conducting a brain scan during a series of perceptual and linguistic tasks
Naive schizophrenic patients
Naive patients with a diagnosis of schizophrenia, a history of only one psychotic episode and un-medicated
Device: Magnetoencephalograph (MEG)
Conducting a brain scan during a series of perceptual and linguistic tasks
Chronic schizophrenia patients
Chronic patients with a diagnosis of schizophrenia and a history of more than one psychotic episode
Device: Magnetoencephalograph (MEG)
Conducting a brain scan during a series of perceptual and linguistic tasks

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
Time Frame
Magnetic field amplitude and source
Time Frame: 45 minutes
45 minutes

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: Hilik Levkovitz, Professor, Shalvata MHC

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.
March 1, 2012

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.
March 1, 2014

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).
March 7, 2012

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.
March 7, 2012

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.
March 9, 2012

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.
March 9, 2012

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.
March 7, 2012

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.
March 1, 2012

More Information

Terms related to this study

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.
  • SHA-0001-12

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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