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

Not Applicable

Completed

• Conditions: Multiple Sclerosis
• Interventions: Other: Brain MRI - Clinical and cognitive evaluation; Device: MRI

• Registration Number: NCT02290587
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-05
• Study First Submitted QC: 2014-11-13
• Study First Posted: 2014-11-14
• Study Start: 2015-11
• Status Verified: 2017-03
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Last Update Submitted: 2017-03-31
• Last Update Posted: 2017-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient	Brain MRI - Clinical and cognitive evaluation	MS diagnosis according to McDonald criteria (Polman et al., 2005). Relapsing-remitting MS (RRMS) according to Lublin et al. (1996);
Control	Brain MRI - Clinical and cognitive evaluation	healthy subject
Patient	MRI	MS diagnosis according to McDonald criteria (Polman et al., 2005). Relapsing-remitting MS (RRMS) according to Lublin et al. (1996);
Control	MRI	healthy subject

Primary Outcome Measures

Name	Time	Method
Brain activation networks during MRI	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

Name	Time	Method
Reduction of volume of deep brain structures and reduction of cortical thickness	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).
White matter skeleton on Fractional Anisotropy (FA) maps established by voxel-based.	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.

Trial Locations

Locations (1)

CHU de Bordeaux; 🇫🇷 Bordeaux, France