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

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ClinicalTrials.gov Identifier: NCT02110017
Recruitment Status : Unknown
Verified February 2015 by University Hospital, Caen.
Recruitment status was:  Recruiting
First Posted : April 10, 2014
Last Update Posted : February 5, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

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 Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 2013
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
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 Name: Philips 3 Tesla fMRI

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 Name: Philips 3 Tesla fMRI




Primary Outcome Measures :
  1. Developing a social cognition ecological task, then testing the reproducibility of the functional magnetic resonance imagery (fMRI) BOLD signal [ Time Frame: 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 :
  1. Identifying a functional deficit among the neural network of social cognition in patients with schizophrenia compared with healthy subjects. [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02110017


Locations
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France
Centre Hospitalier Universitaire Recruiting
Caen, Normandy, France, 14000
Contact: Perrine Brazo, MD-PhD    0033231065018      
Contact: Vincent B Marzloff, MD    0033231064424    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         
Sponsors and Collaborators
University Hospital, Caen
Investigators
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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
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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT02110017    
Other Study ID Numbers: RCB 2013-A00064-41
First Posted: April 10, 2014    Key Record Dates
Last Update Posted: February 5, 2015
Last Verified: February 2015
Keywords provided by University Hospital, Caen:
Ecological task
fMRI
Schizophrenia
Social Cognition
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders