Emotional Processing, Family Life, Friendship and Social Integration in Patients With Multiple Sclerosis

NCT ID: NCT02708927

Last Updated: 2019-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-03
• Study Completion Date: 2019-01-28

Brief Summary

In addition to the physical, cognitive and psychological symptoms experienced by individuals with Multiple Sclerosis (MS), there is new research which indicates that some individuals with MS have a deficit in emotional processing, specifically, facial affect recognition. Emotional processing is defined as "a central aspect of social cognition". Models of social cognition indicate that emotional processing is an essential component of interpersonal relationships. The failure to accurately perceive other's emotions has been shown to lead to difficulty in social relationships, misinterpreting other's affect, and consequently, inappropriate responding.

However, even though a significant number of individuals with MS have impairments in emotional processing, we do not yet have an understanding of how these impairments affect the social functioning of individuals with MS, including the impact of these deficits on family structure. It is well-known that MS impacts one's social functioning including factors such as employment, daily living activities and interpersonal relationships. Recently a strong correlation was observed between reduced social participation in MS and quality of life. There is evidence to suggest that emotional processing deficits lie at the heart of this reduced social participation in persons with MS, leading to decreased social functioning and thus reduced quality of life. However, to date, this hypothesis has not been tested.

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

Clinical evaluation

Intervention Type: OTHER

• Clinical assessment : Expanded Disability Status Scale (EDSS), ambulation test. Medications will be recorded.

Cognitive evaluation

Intervention Type: OTHER

• Neuropsychological, psychological, social and social cognitive evaluation

Control

healthy subject

Group Type: EXPERIMENTAL

Cognitive evaluation

Intervention Type: OTHER

• Neuropsychological, psychological, social and social cognitive evaluation

Interventions

Clinical evaluation

• Clinical assessment : Expanded Disability Status Scale (EDSS), ambulation test. Medications will be recorded.

Intervention Type: OTHER

Cognitive evaluation

• Neuropsychological, psychological, social and social cognitive evaluation

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age 18-45 years;
• MS diagnosis according to McDonald criteria (Polman et al., 2005);
• RRMS;
• Disease duration < 15 years;
• Fluent French speaker;
• Have a significant other (family members or close friends) who was willing to complete the informant questionnaire BAFQ;
• Being affiliated to health insurance;
• Having signed an informed consent (later than the day of inclusion and before any examination required by research).

• Age 18-45 years
• Fluent French speaker;
• Have a significant other (family members or close friends) who was willing to complete the informant questionnaire BAFQ.
• Being affiliated to health insurance
• Having signed an informed consent (later than the day of inclusion and before any examination required by research)

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;
• 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 three month;
• change of psychotropic drug since less than one month;
• Prior neuropsychological testing with the same tests less than one year prevents the participant to participate at this study.
• Illiteracy, is unable to count or to read;
• Being under guardianship.
• Pregnant or breastfeeding women;

• History of neurological disease;
• family history of MS;
• psychiatric comorbidity including severe depression according to DSMIV;
• alcohol or other toxic addiction;
• usage of psychotropic drugs;
• Known cognitive complaint or neuropsychological affection;
• Prior neuropsychological testing with the same tests less than one year prevents the participant to participate at this study.
• Illiteracy, is unable to count or to read;
• Being under guardianship.
• Pregnant or breastfeeding women;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

FONDATION POUR L'AIDE A LA RECHERCHE SUR LA SCLEROSE EN PLAQUES

UNKNOWN

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

CHU de Dijon

Dijon, , France

Countries

France

Other Identifiers

CHUBX 2015/11

Identifier Type: -

Identifier Source: org_study_id