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

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.

Study Overview

• Status: Unknown
• Conditions: Schizophrenia; Interpersonal Relations; Magnetic Resonance Imaging, Functional
• Intervention / Treatment: Other: fMRI social cognition task

Detailed Description

Social cognition neural basis. Impairment of the "social brain" in schizophrenia

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Normandy
    • Caen, Normandy, France, 14000
      • Recruiting
      • Centre hospitalier universitaire
      • Contact: Perrine Brazo, MD-PhD; Phone Number: 0033231065018
      • Contact: Vincent B Marzloff, MD; Phone Number: 0033231064424; Email: marzloff-v@chu-caen.fr
      • Principal Investigator: Perrine BRAZO, MD-PhD
      • Principal Investigator: Sonia DOLLFUS, MD-PhD
      • Principal Investigator: Pascal DELAMILLIEURE, MD-PhD
      • Principal Investigator: Vincent MARZLOFF, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patients with schizophrenia; 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.	Other: fMRI social cognition task; 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.; Other Names: Philips 3 Tesla fMRI
Other: Healthy subjects; Twenty healthy subjects (no mental or neurological disease) After anatomic scans, each subject will go through the fMRI social cognition task.	Other: fMRI social cognition task; 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.; Other Names: Philips 3 Tesla fMRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Day 1 for individual analysis. Up to 24 months for group analysis.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1 for individual analysis. Up to 24 months for group analysis.

Collaborators and Investigators

• Sponsor: University Hospital, Caen
• Investigators: Principal Investigator: Perrine BRAZO, MD-PhD, 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

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Anticipated): September 1, 2015
• Study Completion (Anticipated): September 1, 2015

Study Registration Dates

• First Submitted: September 12, 2013
• First Submitted That Met QC Criteria: April 8, 2014
• First Posted (Estimate): April 10, 2014

Study Record Updates

• Last Update Posted (Estimate): February 5, 2015
• Last Update Submitted That Met QC Criteria: February 4, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Schizophrenia; fMRI; Social Cognition; Ecological task
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: RCB 2013-A00064-41