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Completed

NCT Number: NCT02290587

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Cognition Disorders Cognitive Dysfunction Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Bordeaux

Bordeaux, 33000, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brain MRI - Clinical and cognitive evaluation

Other

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

MRI

Device

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Collaborators

  • La Ligue Française Contre la Sclérose en Plaques

Registry information

Acronym: SOCOG-MS

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 14, 2014
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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