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

NCT02708927 | Completed

• 1 other identifier: CHUBX 2015/11
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 2

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

Keywords

social integration; cognitive impairment; emotional processing; quality of life

Outcome Measures

Primary Outcomes (1)

• Interaction between measures of emotional processing (z score) and functional measures of social interaction

  among the 3 groups (impaired MS, no impaired MS and HS)

  At inclusion (day 0)

Secondary Outcomes (3)

• Correlation between measures of emotional processing with cognitive testing (z scores by domain) and cognitive functioning evaluated by significant other

  At inclusion (day 0)

• Correlation between measures of emotional processing and quality of life measures

  At inclusion (day 0)

• Impact of the cognitive impairment on the relationship of emotional processing (z score) with interpersonal relationships (family, friendship, marital) and society integration and social functioning.

  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: Clinical evaluation; Other: Cognitive evaluation

Control

EXPERIMENTAL

healthy subject

Other: Cognitive evaluation

Interventions

Clinical evaluation OTHER

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

patient

Cognitive evaluation OTHER

• Neuropsychological, psychological, social and social cognitive evaluation

Control; patient

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• 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

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;
• 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;

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• FONDATION POUR L'AIDE A LA RECHERCHE SUR LA SCLEROSE EN PLAQUES: collaborator

Study Sites (2)

CHU de Bordeaux

Bordeaux, 33000, France

Location

CHU de Dijon

Dijon, 21079, 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: March 10, 2016
• First Posted: March 15, 2016
• Study Start: March 3, 2016
• Primary Completion: January 28, 2019
• Study Completion: January 28, 2019
• Last Updated: February 5, 2019

Record last verified: 2019-02

Locations

FR (2)