Exploration of Neural Bases in Social Cognition

NCT02110017 | Unknown

• 1 other identifier: RCB 2013-A00064-41
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Interpersonal Relations; Schizophrenia; Magnetic Resonance Imaging, Functional

Keywords

Ecological task; fMRI; Schizophrenia; Social Cognition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (2)

Patients with schizophrenia

OTHER

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

Healthy subjects

OTHER

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

Interventions

fMRI social cognition task OTHER

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.

Also known as: Philips 3 Tesla fMRI

Healthy subjects; Patients with schizophrenia

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• )For healthy subjects:
• without any psychiatric affection (Mini International Neuropsychiatric Interview)
• )For patients
• meeting the DSM-IV-R criteria for schizophrenia or schizoaffective disorder

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Centre Hospitalier Universitaire

Caen, Normandy, 14000, France

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2013
• First Posted: April 10, 2014
• Study Start: September 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: February 5, 2015

Record last verified: 2015-02

Locations

FR (1)