IRM-COG: Exploration of Neural Bases in Social Cognition

Sponsor

University Hospital, Caen (Other)

Overall Status

Unknown status

CT.gov ID

NCT02110017

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Interpersonal Relations Schizophrenia Magnetic Resonance Imaging, Functional	Other: fMRI social cognition task	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

Exploration of Neural Bases in Social Cognition

Study Start Date :

Sep 1, 2013

Anticipated Primary Completion Date :

Sep 1, 2015

Anticipated Study Completion Date :

Sep 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Developing a social cognition ecological task, then testing the reproducibility of the functional magnetic resonance imagery (fMRI) BOLD signal [Day 1 for individual analysis. Up to 24 months for group analysis.]
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. [Day 1 for individual analysis. Up to 24 months for group analysis.]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier Universitaire	Caen	Normandy	France	14000

Sponsors and Collaborators

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