Magnetoencephalographic (MEG) Correlates of Negative Symptoms in Patients Suffering From Schizophrenia and Their Influence by Add-on Treatments

January 4, 2012 updated by: Shalvata Mental Health Center

The objective of the suggested study is to identify changes in MEG correlates caused by the add-on treatment with the changes in negative symptoms of schizophrenia by comparing the change in the MEG correlates of the subjects before and during usage of new add on treatments for negative symptoms.

The investigators hypothesize that the gravity of negative symptoms will correlate with a trend towards more aberrant electroencephalographic correlates mainly in continuous parameters, with an emphasis on alpha and delta bands

Study Overview

Status

Unknown

Conditions

Detailed Description

There is a paucity of information regarding electrophysiological correlates of negative symptoms in patients suffering from schizophrenia. The proposed study is set out to compare the MEG correlates of negative symptoms in patients suffering from schizophrenia to those of healthy controls in terms of both relevant ERP components and quantified (continuous) MEG.

The presented study will include two parts: Part A will explore the electrophisological correlates of negative symptoms in patients suffering from schizophrenia using MEG. The study will do so by comparing the electrophisological correlates of schizophrenia patients suffering from negative symptoms and stable on psychiatric treatment to those of healthy controls. In the second part of the study data from part A of patients that have started new add-on treatments for negative symptoms will be compared to parallel data acquired after stabilization on the new treatment.

Study Type

Observational

Enrollment (Anticipated)

50

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

  • Israel
      • Givat Shmuel, Israel
        • Recruiting
        • Bar-Ilan University
        • Contact:
          • Liron Rabani, MA
          • Phone Number: 09 7478644
        • Principal Investigator:
          • Liron Rabany, MA

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

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

schizophrenia patients and healthy subjects between the ages 18-65

Description

Inclusion Criteria:

  • Study Group (Schizophrenia Patients) Inclusion Criteria
  • Patients between the ages of 18-65 (male and female), Diagnosed in the past as suffering from schizophrenia. The diagnosis will be reaffirmed according to ICD criteria.
  • Right hand dominant.
  • Scores in PANSS negative questionnaire above 21 and positive symptom less than 24.
  • Gave informed consent for participation in the study.
  • Stable on the same antipsychotic medication for at least a month prior to entering the study Control Group (healthy Subjects)

Inclusion criteria:

  • Healthy man and woman
  • Ages 18-65
  • Right handed

Exclusion Criteria:

  • Study Group (Schizophrenia Patients) (To prevent MEG artifacts by non relevant electric interference or brain conditions)
  • History of epilepsy, seizure, or hot spasm, sever head injuries.
  • History of metal in the head (outside the mouth space).
  • History of surgery including metal implant or history of metal particles in the eye, pacemaker, or any other medical pump.
  • History of migraines.
  • History of drug or alcohol abuse during the last year. Inability to achieve satisfying level of communication with the subject Control Group (healthy Subjects)
  • History of psychiatric diagnosis
  • Drug or alcohol addiction in the year prior to the study
  • History of epilepsy, seizure, or hot spasm.
  • History of head injuries.
  • History of metal in the head (outside the mouth space).
  • History of surgery including metal implant or history of metal particles in the eye, pacemaker, or any other medical pump.
  • History of migraines.
  • Use of psychotropic medication

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: Prospective

Cohorts and Interventions

Group / Cohort
1
schizophrenia patients
2
healthy control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Primary outcome measures will include continuous and ERP (Event Related Potential) MEG (Magnetoencephalograph) data
Time Frame: four months
four months

Collaborators and Investigators

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

Sponsor

Shalvata Mental Health Center

Collaborators

Bar-Ilan University, Israel

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

March 1, 2009

Primary Completion (Anticipated)

January 1, 2013

Study Completion (Anticipated)

January 1, 2013

Study Registration Dates

First Submitted

May 5, 2009

First Submitted That Met QC Criteria

May 5, 2009

First Posted (Estimate)

May 6, 2009

Study Record Updates

Last Update Posted (Estimate)

January 5, 2012

Last Update Submitted That Met QC Criteria

January 4, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0027-08-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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