Emotional Processing, Family Life, Friendship and Social Integration in Patients With Multiple Sclerosis (EMOSOCIAL-MS)

February 1, 2019 updated by: University Hospital, Bordeaux

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

91

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33000
        • CHU de Bordeaux
      • Dijon, France, 21079
        • CHU de Dijon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria (patient group):

  • 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).

Inclusion Criteria (healthy control):

  • 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 (patient group):

  • 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;

Exclusion Criteria (healthy control):

  • 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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: patient
MS diagnosis according to McDonald criteria (Polman et al., 2005). Relapsing-remitting MS (RRMS) according to Lublin et al. (1996);
Other: Clinical evaluation
• Clinical assessment : Expanded Disability Status Scale (EDSS), ambulation test. Medications will be recorded.
Other: Cognitive evaluation
• Neuropsychological, psychological, social and social cognitive evaluation
Experimental: Control
healthy subject
Other: Cognitive evaluation
• Neuropsychological, psychological, social and social cognitive evaluation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interaction between measures of emotional processing (z score) and functional measures of social interaction
Time Frame: At inclusion (day 0)
among the 3 groups (impaired MS, no impaired MS and HS)
At inclusion (day 0)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between measures of emotional processing with cognitive testing (z scores by domain) and cognitive functioning evaluated by significant other
Time Frame: At inclusion (day 0)
(BAFQ)
At inclusion (day 0)
Correlation between measures of emotional processing and quality of life measures
Time Frame: At inclusion (day 0)
(MUSIQoL questionnaire).
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.
Time Frame: At inclusion (day 0)
At inclusion (day 0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Collaborators

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

Investigators

  • Principal Investigator: Bruno BROCHET, Prof, CHU Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2016

Primary Completion (Actual)

January 28, 2019

Study Completion (Actual)

January 28, 2019

Study Registration Dates

First Submitted

March 10, 2016

First Submitted That Met QC Criteria

March 10, 2016

First Posted (Estimate)

March 15, 2016

Study Record Updates

Last Update Posted (Actual)

February 5, 2019

Last Update Submitted That Met QC Criteria

February 1, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2015/11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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