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

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ClinicalTrials.gov Identifier: NCT02290587
Recruitment Status : Completed
First Posted : November 14, 2014
Last Update Posted : April 4, 2017
Sponsor:
Collaborator:
La Ligue Française Contre la Sclérose en Plaques
Information provided by (Responsible Party):
University Hospital, Bordeaux

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Other: Brain MRI - Clinical and cognitive evaluation Device: MRI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Study of Social Cognition by Morphological and Functional Imaging in Multiple Sclerosis Patients
Actual Study Start Date : November 2015
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patient
MS diagnosis according to McDonald criteria (Polman et al., 2005). Relapsing-remitting MS (RRMS) according to Lublin et al. (1996);
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

Device: MRI
Experimental: Control
healthy subject
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

Device: MRI



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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): NCT02290587


Locations
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France
CHU de Bordeaux
Bordeaux, France, 33000
Sponsors and Collaborators
University Hospital, Bordeaux
La Ligue Française Contre la Sclérose en Plaques
Investigators
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Principal Investigator: Bruno Brochet, Prof. CHU - Bordeaux
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT02290587    
Other Study ID Numbers: CHUBX 2014/01
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: March 2017
Keywords provided by University Hospital, Bordeaux:
social cognitive
theory of mind
cognitive impairment
functional MRI
brain activation network
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases