Study of Social Cognition by Morphological and Functional Imaging in Multiple Sclerosis Patients (SOCOG-MS)

May 11, 2026 updated by: University Hospital, Bordeaux
In recent years, studies have brought knowledge of the difficulties of social cognition in Multiple Sclerosis (MS). The brain tissue alteration at the origin of these difficulties in social cognition mechanisms remain poorly understood. Although recent behavioral studies indicated social disturbances in many of these patients, functional studies investigating specific theory of mind in MS are lacking. The use of new techniques for morphological and functional Magnetic Resonance Imaging (MRI) can identify brain activation networks, mapping the achievement and tissue integrity may be related to disorders of social cognition and cognitive. The investigators propose to study social cognition in MS patients using morphological and functional imaging to determine the mechanisms underlying phenomena such as cerebral compensation and its relationship with cognitive impairment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33000
        • CHU de Bordeaux

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 59 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria (patient group):

  • Aged 18-59 years
  • Right handed
  • Fluent French speaker
  • MS diagnosis according to McDonald criteria (Polman et al., 2005).
  • Relapsing-remitting MS (RRMS) according to Lublin et al. (1996);
  • Having signed an informed consent (later than the day of inclusion and before any examination required by research)
  • Being affiliated to health insurance

Inclusion Criteria (healthy control):

  • Aged 18-59 years
  • Right handed
  • Fluent French speaker
  • Having signed an informed consent (later than the day of inclusion and before any examination required by research)
  • Being affiliated to health insurance

Exclusion Criteria (patient group):

  • Other progressive neurological disease;
  • psychiatric comorbidity including severe depression according to Diagnostic and Statistical Manual-IV (DSM-IV),
  • alcohol or other addiction to toxic,
  • Expanded Disability Status Scale (EDSS) > 6; disabling visual or motor problems preventing participation to neuropsychological assessments,
  • relapse since less than one month,
  • change of disease-modifying therapy or psychotropic drug since less than one month,
  • Contra-indication to MRI (pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body, claustrophobia) or refusing MRI
  • Illiteracy, is unable to count or to read
  • Pregnant or breastfeeding women
  • Being under guardianship

Exclusion Criteria (healthy control):

  • History of neurological disease;
  • family history of MS;
  • psychiatric comorbidity including severe depression according to DSM-IV;
  • alcohol or other toxic addiction;
  • psychotropic drugs; known cognitive complaint or neuropsychological affection;
  • Prior neuropsychological testing with the same tests less than one year
  • Contra-indication to MRI (pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body, claustrophobia) or refusing MRI
  • Illiteracy, is unable to count or to read
  • Pregnant or breastfeeding women
  • Being under guardianship

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Control
healthy subject
Device: MRI
Other: Brain MRI - Clinical and cognitive evaluation

Neuropsychological evaluation :

  • Questionnaire for depression and anxiety
  • Evaluation of executive functions
  • Evaluation of attention, information processing speed, verbal memory and working memory

Theory of mind evaluation

Clinical Evaluation

MRI Evaluation :

  • morphological MRI
  • functional MRI with two tasks of theory of mind : eyes test and test of attribution of intention
Experimental: Patient
MS diagnosis according to McDonald criteria (Polman et al., 2005). Relapsing-remitting MS (RRMS) according to Lublin et al. (1996);
Device: MRI
Other: Brain MRI - Clinical and cognitive evaluation

Neuropsychological evaluation :

  • Questionnaire for depression and anxiety
  • Evaluation of executive functions
  • Evaluation of attention, information processing speed, verbal memory and working memory

Theory of mind evaluation

Clinical Evaluation

MRI Evaluation :

  • morphological MRI
  • functional MRI with two tasks of theory of mind : eyes test and test of attribution of intention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain activation networks during MRI
Time Frame: At inclusion (day 0)
To identify brain activation networks during the two paradigms of theory of mind and executive function in RRMS patients taking into account cognitive impairment.
At inclusion (day 0)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of volume of deep brain structures and reduction of cortical thickness
Time Frame: At inclusion (day 0)
Correlation between social cognitive z scores and atrophy measures (reduction of volume of deep brain structures and reduction of cortical thickness).
At inclusion (day 0)
White matter skeleton on Fractional Anisotropy (FA) maps established by voxel-based.
Time Frame: At inclusion (day 0)
Comparison of white matter skeleton on Fractional Anisotropy (FA) maps established by voxel-based between RRMS patients and Healthy Control (HC) patients and in RRMS group taking into account cognitive impairment.
At inclusion (day 0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Collaborators

La Ligue Française Contre la Sclérose en Plaques

Investigators

  • Principal Investigator: Bruno Brochet, Prof., University Hospital, Bordeaux

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2015

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

November 5, 2014

First Submitted That Met QC Criteria

November 13, 2014

First Posted (Estimated)

November 14, 2014

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2014/01
  • 2014-A01286-41 (Other Identifier: ANSM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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