Normal and Abnormal ERP During ToM and Emotional Conflicts in Schizophrenia

NCT ID: NCT02896374

Last Updated: 2018-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2017-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Schizophrenia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients

Treated or hospitalized patients for schizophrenia.

Group Type EXPERIMENTAL

Theory of mind without visual cues

Intervention Type BEHAVIORAL

Theory of mind stimulation without visual reinforcement while performing EEG recordings

Theory of mind without visual cues

Intervention Type BEHAVIORAL

Theory of mind stimulation with visual reinforcement while performing EEG recordings

Control

No schizophrenic participants, comparable to schizophrenia patients in age, gender, education level and socio premorbid verbal IQ.

Group Type EXPERIMENTAL

Theory of mind without visual cues

Intervention Type BEHAVIORAL

Theory of mind stimulation without visual reinforcement while performing EEG recordings

Theory of mind without visual cues

Intervention Type BEHAVIORAL

Theory of mind stimulation with visual reinforcement while performing EEG recordings

Interventions

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Theory of mind without visual cues

Theory of mind stimulation without visual reinforcement while performing EEG recordings

Intervention Type BEHAVIORAL

Theory of mind without visual cues

Theory of mind stimulation with visual reinforcement while performing EEG recordings

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Versailles Hospital

OTHER

Sponsor Role lead

Responsible Party

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Eric BRUNET

Investigator coordinator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eric Brunet, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Versailles Hospital

Locations

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Centre Hospitalier de Versailles

Le Chesnay, , France

Site Status

Countries

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France

Other Identifiers

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P11/16_SERC

Identifier Type: -

Identifier Source: org_study_id

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