Clinical trial NCT02290587: Study of Social Cognition by Morphological and Functional Imaging in Multiple Sclerosis Patients
Official title: Study of Social Cognition by Morphological and Functional Imaging in Multiple Sclerosis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: social cognitive
theory of mind
cognitive impairment
functional MRI
brain activation network
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: La Ligue Française Contre la Sclérose en Plaques
First posted: 2014-11-14
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Brain activation networks during MRI
timeFrame: At inclusion (day 0)
Secondary outcomes:
measure: Reduction of volume of deep brain structures and reduction of cortical thickness
timeFrame: At inclusion (day 0)
measure: White matter skeleton on Fractional Anisotropy (FA) maps established by voxel-based.
timeFrame: At inclusion (day 0)
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
Study officials:
affiliation: University Hospital, Bordeaux
name: Bruno Brochet, Prof.
role: PRINCIPAL_INVESTIGATOR
References: