Normal and Abnormal ERP During ToM and Emotional Conflicts in Schizophrenia (SERC)

March 21, 2018 updated by: Eric BRUNET, Versailles Hospital

Normal and Abnormal Event Related Potentials During Attribution of Intentions to Others and Resolution of Emotional Conflicts in Schizophrenia

Case-control comparison of clinical population, interventional and single-center research.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The main objective of this study is to define and characterize electrophysiological markers of the existing social cognition disorders in schizophrenia. Two groups of subjects are recorded : schizophrenic patients and healthy controls. Visual reinforcement effect during theory of mind judgment is tested.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

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

  • France
      • Le Chesnay, France, 78150
        • Centre Hospitalier de Versailles

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

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Written informed consent French mother tongue Schizophrenia diagnosis according to DSM-IV-R for the patient group

Exclusion Criteria:

Coma history, epilepsy, head trauma with loss knowledge greater 10 min ECT older than 1 month DSM-4 R criteria of toxic addiction in the last 6 months Deafness or blindness Scalp pathology Intracranial implanted device

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

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients
Treated or hospitalized patients for schizophrenia.
Behavioral: Theory of mind without visual cues
Theory of mind stimulation without visual reinforcement while performing EEG recordings
Behavioral: Theory of mind without visual cues
Theory of mind stimulation with visual reinforcement while performing EEG recordings
Experimental: Control
No schizophrenic participants, comparable to schizophrenia patients in age, gender, education level and socio premorbid verbal IQ.
Behavioral: Theory of mind without visual cues
Theory of mind stimulation without visual reinforcement while performing EEG recordings
Behavioral: Theory of mind without visual cues
Theory of mind stimulation with visual reinforcement while performing EEG recordings

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event related electric amplitudes
Time Frame: Day 0
Scalp EEG recordings (microvolts) with respect to average or vertex references
Day 0

Collaborators and Investigators

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

Sponsor

Versailles Hospital

Investigators

  • Principal Investigator: Eric Brunet, MD PhD, Versailles Hospital

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 (Actual)

March 1, 2013

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

August 19, 2016

First Submitted That Met QC Criteria

September 6, 2016

First Posted (Estimate)

September 12, 2016

Study Record Updates

Last Update Posted (Actual)

March 22, 2018

Last Update Submitted That Met QC Criteria

March 21, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P11/16_SERC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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