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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Brain MRI - Clinical and cognitive evaluation
MRI
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Multiple Sclerosis focused on measuring social cognitive, theory of mind, cognitive impairment, functional MRI, brain activation network

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CHU de Bordeaux

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Patient

Control

Arm Description

MS diagnosis according to McDonald criteria (Polman et al., 2005). Relapsing-remitting MS (RRMS) according to Lublin et al. (1996);

healthy subject

Outcomes

Primary Outcome Measures

Brain activation networks during MRI
To identify brain activation networks during the two paradigms of theory of mind and executive function in RRMS patients taking into account cognitive impairment.

Secondary Outcome Measures

Reduction of volume of deep brain structures and reduction of cortical thickness
Correlation between social cognitive z scores and atrophy measures (reduction of volume of deep brain structures and reduction of cortical thickness).
White matter skeleton on Fractional Anisotropy (FA) maps established by voxel-based.
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.

Full Information

First Posted
November 5, 2014
Last Updated
March 31, 2017
Sponsor
University Hospital, Bordeaux
Collaborators
La Ligue Française Contre la Sclérose en Plaques
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1. Study Identification

Unique Protocol Identification Number
NCT02290587
Brief Title
Study of Social Cognition by Morphological and Functional Imaging in Multiple Sclerosis Patients
Acronym
SOCOG-MS
Official Title
Study of Social Cognition by Morphological and Functional Imaging in Multiple Sclerosis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
Collaborators
La Ligue Française Contre la Sclérose en Plaques

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
social cognitive, theory of mind, cognitive impairment, functional MRI, brain activation network

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient
Arm Type
Experimental
Arm Description
MS diagnosis according to McDonald criteria (Polman et al., 2005). Relapsing-remitting MS (RRMS) according to Lublin et al. (1996);
Arm Title
Control
Arm Type
Experimental
Arm Description
healthy subject
Intervention Type
Other
Intervention Name(s)
Brain MRI - Clinical and cognitive evaluation
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
MRI
Primary Outcome Measure Information:
Title
Brain activation networks during MRI
Description
To identify brain activation networks during the two paradigms of theory of mind and executive function in RRMS patients taking into account cognitive impairment.
Time Frame
At inclusion (day 0)
Secondary Outcome Measure Information:
Title
Reduction of volume of deep brain structures and reduction of cortical thickness
Description
Correlation between social cognitive z scores and atrophy measures (reduction of volume of deep brain structures and reduction of cortical thickness).
Time Frame
At inclusion (day 0)
Title
White matter skeleton on Fractional Anisotropy (FA) maps established by voxel-based.
Description
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.
Time Frame
At inclusion (day 0)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno Brochet, Prof.
Organizational Affiliation
CHU Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33000
Country
France

12. IPD Sharing Statement

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Study of Social Cognition by Morphological and Functional Imaging in Multiple Sclerosis Patients

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