NCT01550211

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 9, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Last Updated

March 9, 2012

Status Verified

March 1, 2012

Enrollment Period

2 years

First QC Date

March 7, 2012

Last Update Submit

March 7, 2012

Conditions

Schizophrenic Patients

Outcome Measures

Primary Outcomes (1)

  • Magnetic field amplitude and source

    45 minutes

Study Arms (4)

Students

Healthy students from Bar-Ilan University

Device: Magnetoencephalograph (MEG)

Schizophrenic patients' relatives

Healthy family members (parents or siblings) of the schizophrenic participants (chronic and naive)

Device: Magnetoencephalograph (MEG)

Naive schizophrenic patients

Naive patients with a diagnosis of schizophrenia, a history of only one psychotic episode and un-medicated

Device: Magnetoencephalograph (MEG)

Chronic schizophrenia patients

Chronic patients with a diagnosis of schizophrenia and a history of more than one psychotic episode

Device: Magnetoencephalograph (MEG)

Interventions

Magnetoencephalograph (MEG)DEVICE

Conducting a brain scan during a series of perceptual and linguistic tasks

Chronic schizophrenia patientsNaive schizophrenic patientsSchizophrenic patients' relativesStudents

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Hebrew native speakers.
  • Diagnosis of schizophrenia with a history of more than one episode.
  • Capable and willing to provide informed consent.
  • Hebrew native speakers.
  • Diagnosis of schizophrenia with a history of only one episode and unmedicated.
  • Capable and willing to provide informed consent.
  • Hebrew native speakers.
  • Without any psychiatric history.
  • Have a child and/or a sibling with schizophrenia.
  • Hebrew native speakers.
  • Without any psychiatric history.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shalvata MHC

Hod HaSharon, Israel

Location

Study Officials

  • Hilik Levkovitz, Professor

    Shalvata MHC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maor Zeev-Wolf, M.A.

CONTACT

972-50-7737032maorwolf@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2012

First Posted

March 9, 2012

Study Start

March 1, 2012

Primary Completion

March 1, 2014

Last Updated

March 9, 2012

Record last verified: 2012-03

Locations

IL(1)