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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01550211
Other study ID # SHA-0001-12
Secondary ID
Status Not yet recruiting
Phase N/A
First received March 7, 2012
Last updated March 7, 2012
Start date March 2012

Study information

Verified date March 2012
Source Shalvata Mental Health Center
Contact Maor Zeev-Wolf, M.A.
Phone 972-50-7737032
Email maorwolf@gmail.com
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 150
Est. completion date
Est. primary completion date March 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Device:
Magnetoencephalograph (MEG)
Conducting a brain scan during a series of perceptual and linguistic tasks

Locations

Country Name City State
Israel Shalvata MHC Hod-Hasharon

Sponsors (2)

Lead Sponsor Collaborator
Shalvata Mental Health Center Bar-Ilan University, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Magnetic field amplitude and source 45 minutes No