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

NCT02290587 | Completed

• 1 other identifier: CHUBX 2014/01
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

social cognitive; theory of mind; cognitive impairment; functional MRI; brain activation network

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Reduction of volume of deep brain structures and reduction of cortical thickness

  At inclusion (day 0)

• White matter skeleton on Fractional Anisotropy (FA) maps established by voxel-based.

  At inclusion (day 0)

Study Arms (2)

Patient

EXPERIMENTAL

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; Device: MRI

Control

EXPERIMENTAL

healthy subject

Other: Brain MRI - Clinical and cognitive evaluation; Device: MRI

Interventions

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

Control; Patient

MRI DEVICE

Control; Patient

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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);
• Being affiliated to health insurance
• Aged 18-59 years
• Right handed
• Fluent French speaker
• Being affiliated to health insurance

You may not qualify if:

• 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
• 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;

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• La Ligue Française Contre la Sclérose en Plaques: collaborator

Study Sites (1)

CHU de Bordeaux

Bordeaux, 33000, France

Location

MeSH Terms

Conditions

Multiple Sclerosis; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Bruno Brochet, Prof.

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2014
• First Posted: November 14, 2014
• Study Start: November 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: April 4, 2017

Record last verified: 2017-03

Locations

FR (1)