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

Multiple Sclerosis Clinical Trial

— SOCOG-MS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02290587
• Other study ID #: CHUBX 2014/01
• Status: Completed
• Phase: N/A
• First received: November 5, 2014
• Last updated: March 31, 2017
• Start date: November 2015
• Est. completion date: March 2017

Study information

• Verified date: March 2017
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	La Ligue Française Contre la Sclérose en Plaques

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At inclusion (day 0)
Secondary	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).	At inclusion (day 0)
Secondary	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.	At inclusion (day 0)