Back to resultsNormal and Abnormal ERP During ToM and Emotional Conflicts in Schizophrenia (SERC)
Primary Purpose
Schizophrenia
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Theory of mind without visual cues
Theory of mind without visual cues
Sponsored by
About this trial
This is an interventional diagnostic trial for Schizophrenia
Eligibility Criteria
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
Sites / Locations
- Centre Hospitalier de Versailles
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Patients
Control
Arm Description
Treated or hospitalized patients for schizophrenia.
No schizophrenic participants, comparable to schizophrenia patients in age, gender, education level and socio premorbid verbal IQ.
Outcomes
Primary Outcome Measures
Event related electric amplitudes
Scalp EEG recordings (microvolts) with respect to average or vertex references
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02896374
Brief Title
Normal and Abnormal ERP During ToM and Emotional Conflicts in Schizophrenia
Acronym
SERC
Official Title
Normal and Abnormal Event Related Potentials During Attribution of Intentions to Others and Resolution of Emotional Conflicts in Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
March 2013 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Versailles Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Case-control comparison of clinical population, interventional and single-center research.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients
Arm Type
Experimental
Arm Description
Treated or hospitalized patients for schizophrenia.
Arm Title
Control
Arm Type
Experimental
Arm Description
No schizophrenic participants, comparable to schizophrenia patients in age, gender, education level and socio premorbid verbal IQ.
Intervention Type
Behavioral
Intervention Name(s)
Theory of mind without visual cues
Intervention Description
Theory of mind stimulation without visual reinforcement while performing EEG recordings
Intervention Type
Behavioral
Intervention Name(s)
Theory of mind without visual cues
Intervention Description
Theory of mind stimulation with visual reinforcement while performing EEG recordings
Primary Outcome Measure Information:
Title
Event related electric amplitudes
Description
Scalp EEG recordings (microvolts) with respect to average or vertex references
Time Frame
Day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Brunet, MD PhD
Organizational Affiliation
Versailles Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier de Versailles
City
Le Chesnay
ZIP/Postal Code
78150
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Normal and Abnormal ERP During ToM and Emotional Conflicts in Schizophrenia
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