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Exploration of Neural Bases in Social Cognition (IRM-COG)

Primary Purpose

Interpersonal Relations, Schizophrenia, Magnetic Resonance Imaging, Functional

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
fMRI social cognition task
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Interpersonal Relations focused on measuring Ecological task, fMRI, Schizophrenia, Social Cognition

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Subjects aged from 18 to 60 years old
  • who have signed a consent and, if there is one, whose legal representant has signed a consent

    1)For healthy subjects:

  • without any psychiatric affection (Mini International Neuropsychiatric Interview)

    2)For patients

  • meeting the DSM-IV-R criteria for schizophrenia or schizoaffective disorder

Exclusion Criteria:

  • pregnant woman
  • neurological affection
  • medical objection to Magnetic Resonance Imagery (MRI)

Sites / Locations

  • Centre Hospitalier UniversitaireRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Patients with schizophrenia

Healthy subjects

Arm Description

Twenty patients suffering from schizophrenia (DSM-IV-R), with medication and medical care. No recent relapse of the psychotic disease, nor change in medications. No neurological comorbidity. After anatomic scans, each subject will go through the fMRI social cognition task.

Twenty healthy subjects (no mental or neurological disease) After anatomic scans, each subject will go through the fMRI social cognition task.

Outcomes

Primary Outcome Measures

Developing a social cognition ecological task, then testing the reproducibility of the functional magnetic resonance imagery (fMRI) BOLD signal
The social cognition paradigm will be developed and the fMRI activations will be compared to those of a visual cartoon based task, known to turn on the neural network of ToM. BOLD signal variations at a high statistical correction ratio (p<0.05) will be explored and compared to the signal of a second fMRI, made on the same 20 healthy subjects one month later, to test reproducibility (% of identical activated voxels during the 2 fMRI, p<0.05)

Secondary Outcome Measures

Identifying a functional deficit among the neural network of social cognition in patients with schizophrenia compared with healthy subjects.
Using the previous social cognition ecological task, BOLD signal variations at a high statistical correction ratio (p<0.05) of 20 patients with schizophrenia will be compared to those of 20 matched healthy subjects.

Full Information

First Posted
September 12, 2013
Last Updated
February 4, 2015
Sponsor
University Hospital, Caen
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1. Study Identification

Unique Protocol Identification Number
NCT02110017
Brief Title
Exploration of Neural Bases in Social Cognition
Acronym
IRM-COG
Official Title
Exploration of Neural Bases in Social Cognition
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2013 (undefined)
Primary Completion Date
September 2015 (Anticipated)
Study Completion Date
September 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
An impairment in social cognition in schizophrenia could account for the severe professional and social difficulties among patients. Social cognition is the way the social world is understood, perceived and interpreted. It includes all the process than enable oneself to interact with another person, namely emotion perception and processing, theory of mind (ToM), social perception, social knowledge and attributional style. Since these process are interconnected, social cognition should be investigated through ecological tasks which activate all of them together. Developing a social cognition ecological task, then testing the reproducibility of the functional magnetic resonance imagery (fMRI) BOLD signal is the main objective of this study. The secondary objective is to seek a functional deficit among the neural network of social cognition in patients with schizophrenia compared with healthy subjects. Forty healthy subjects, aged from 18 to 60 years old, who have given a written consent, will be included. The social cognition paradigm will be developed and the fMRI activations will be compared to those of a visual cartoon based task, known to turn on the neural network of ToM. BOLD signal variations at a high statistical correction ratio (p<0.05) will be explored and compared to the signal of a second fMRI, made on the same 20 healthy subjects one month later, to test reproducibility (% of identical activated voxels during the 2 fMRI, p<0.05). Twenty matched patients with schizophrenia (DSM-IV-R), aged from 18 to 60 will be included to test the secondary objective. We make the hypothesis of a fMRI functional alteration in the cerebral network involved in social cognition, especially in the medial prefrontal cortex, among patients compared with healthy subjects.
Detailed Description
Social cognition neural basis. Impairment of the "social brain" in schizophrenia

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interpersonal Relations, Schizophrenia, Magnetic Resonance Imaging, Functional
Keywords
Ecological task, fMRI, Schizophrenia, Social Cognition

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with schizophrenia
Arm Type
Other
Arm Description
Twenty patients suffering from schizophrenia (DSM-IV-R), with medication and medical care. No recent relapse of the psychotic disease, nor change in medications. No neurological comorbidity. After anatomic scans, each subject will go through the fMRI social cognition task.
Arm Title
Healthy subjects
Arm Type
Other
Arm Description
Twenty healthy subjects (no mental or neurological disease) After anatomic scans, each subject will go through the fMRI social cognition task.
Intervention Type
Other
Intervention Name(s)
fMRI social cognition task
Other Intervention Name(s)
Philips 3 Tesla fMRI
Intervention Description
fMRI social cognition task : each subject will go through 3 runs of a fMRI paradigm, first one verbal then two visual runs, which are meant to activate the theory of mind network.
Primary Outcome Measure Information:
Title
Developing a social cognition ecological task, then testing the reproducibility of the functional magnetic resonance imagery (fMRI) BOLD signal
Description
The social cognition paradigm will be developed and the fMRI activations will be compared to those of a visual cartoon based task, known to turn on the neural network of ToM. BOLD signal variations at a high statistical correction ratio (p<0.05) will be explored and compared to the signal of a second fMRI, made on the same 20 healthy subjects one month later, to test reproducibility (% of identical activated voxels during the 2 fMRI, p<0.05)
Time Frame
Day 1 for individual analysis. Up to 24 months for group analysis.
Secondary Outcome Measure Information:
Title
Identifying a functional deficit among the neural network of social cognition in patients with schizophrenia compared with healthy subjects.
Description
Using the previous social cognition ecological task, BOLD signal variations at a high statistical correction ratio (p<0.05) of 20 patients with schizophrenia will be compared to those of 20 matched healthy subjects.
Time Frame
Day 1 for individual analysis. Up to 24 months for group analysis.

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: Subjects aged from 18 to 60 years old who have signed a consent and, if there is one, whose legal representant has signed a consent 1)For healthy subjects: without any psychiatric affection (Mini International Neuropsychiatric Interview) 2)For patients meeting the DSM-IV-R criteria for schizophrenia or schizoaffective disorder Exclusion Criteria: pregnant woman neurological affection medical objection to Magnetic Resonance Imagery (MRI)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Perrine BRAZO, MD-PhD
Organizational Affiliation
University of Caen, UMR 6301 ISTCT ISTS group; CNRS UMR 6301 ISTCT GIP Cyceron; CEA UMR 6301 ISTCT; CHU de Caen, Department of psychiatry, Centre Esquirol
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire
City
Caen
State/Province
Normandy
ZIP/Postal Code
14000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Perrine Brazo, MD-PhD
Phone
0033231065018
First Name & Middle Initial & Last Name & Degree
Vincent B Marzloff, MD
Phone
0033231064424
Email
marzloff-v@chu-caen.fr
First Name & Middle Initial & Last Name & Degree
Perrine BRAZO, MD-PhD
First Name & Middle Initial & Last Name & Degree
Sonia DOLLFUS, MD-PhD
First Name & Middle Initial & Last Name & Degree
Pascal DELAMILLIEURE, MD-PhD
First Name & Middle Initial & Last Name & Degree
Vincent MARZLOFF, MD

12. IPD Sharing Statement

Learn more about this trial

Exploration of Neural Bases in Social Cognition

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