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

NCT ID: NCT02290587

Last Updated: 2017-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2017-03-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patient

MS diagnosis according to McDonald criteria (Polman et al., 2005). Relapsing-remitting MS (RRMS) according to Lublin et al. (1996);

Group Type: EXPERIMENTAL

Brain MRI - Clinical and cognitive evaluation

Intervention Type: 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

MRI

Intervention Type: DEVICE

Control

healthy subject

Group Type: EXPERIMENTAL

Brain MRI - Clinical and cognitive evaluation

Intervention Type: 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

MRI

Intervention Type: DEVICE

Interventions

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

Intervention Type: OTHER

MRI

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• 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;
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

La Ligue Française Contre la Sclérose en Plaques

OTHER

Sponsor Role: collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bruno Brochet, Prof.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

CHU de Bordeaux

Bordeaux, , France

Countries

France

Other Identifiers

CHUBX 2014/01

Identifier Type: -

Identifier Source: org_study_id