Multiple SclerosisEMOSOCIAL-MSNCT02708927
Emotional Processing, Family Life, Friendship and Social Integration in Patients With Multiple Sclerosis
A study testing Clinical evaluation and Cognitive evaluation in people with Multiple Sclerosis, run by University Hospital, Bordeaux at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Clinical evaluation and Cognitive evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 2 sitesFrance
- Study dates
- 3 Mar 2016to 28 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
Show all 13Show fewer
- 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)
Who cannot join
- 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;
Show all 22Show fewer
- 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;
Trial locations and contacts
2 sites in 1 country.
About this study
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
- Being tested
- Clinical evaluation, Cognitive evaluation
- Keywords
- social integration, cognitive impairment, emotional processing, quality of life
- Medical subject headings
- Multiple Sclerosis, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical evaluationOther
- Clinical assessment : Expanded Disability Status Scale (EDSS), ambulation test. Medications will be recorded.
Cognitive evaluationOther
- Neuropsychological, psychological, social and social cognitive evaluation
| Study group | Role | What they receive |
|---|---|---|
| patient | Experimental | MS diagnosis according to McDonald criteria (Polman et al., 2005). Relapsing-remitting MS (RRMS) according to Lublin et al. (1996); Receives: Other: Clinical evaluation; Other: Cognitive evaluation |
| Control | Experimental | healthy subject Receives: Other: Cognitive evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
(BAFQ)
Measured: At inclusion (day 0)
Correlation between measures of emotional processing and quality of life measures
(MUSIQoL questionnaire).
Measured: 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.
Measured: At inclusion (day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2016 (estimated)
- Study start3 Mar 2016
- Primary completion28 Jan 2019
- Study completion28 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- FONDATION POUR L'AIDE A LA RECHERCHE SUR LA SCLEROSE EN PLAQUES
- Responsible party
- Sponsor
- Investigators
- Bruno BROCHET, Prof, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02708927
- Sponsor's protocol ID
- CHUBX 2015/11
- Acronym
- EMOSOCIAL-MS
- Status last verified
- Feb 2019
- First submitted
- 10 Mar 2016
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Brochet B, Moreau T, Saubusse A, Charre-Morin J, Lamargue D, Deloire M, Ruet A. Episodic memory deficits are associated with social cognitive impairments in multiple sclerosis. J Neurol. 2026 Aug 20;273(9):534. doi: 10.1007/s00415-026-14067-7.
PubMed 42622682
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotional Processing, Family Life, Friendship and Social Integration in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02708927
- Acronym / sponsor ID
- EMOSOCIAL-MS / CHUBX 2015/11
- Conditions
- Multiple Sclerosis
- Keywords
- social integration, cognitive impairment, emotional processing, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- FONDATION POUR L'AIDE A LA RECHERCHE SUR LA SCLEROSE EN PLAQUES
- Study start
- 3 Mar 2016 (actual)
- Primary completion
- 28 Jan 2019 (actual)
- Study completion
- 28 Jan 2019 (actual)
- First posted
- 15 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient | Experimental | Other: Clinical evaluation, Other: Cognitive evaluationMS diagnosis according to McDonald criteria (Polman et al., 2005). Relapsing-remitting MS (RRMS) according to Lublin et al. (1996); |
| Control | Experimental | Other: Cognitive evaluationhealthy subject |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Age 18-45 years;
- MS diagnosis according to McDonald criteria (Polman et al., 2005);
- RRMS;
- Disease duration < 15 years;
- Fluent French speaker;
Key exclusion criteria (22 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical evaluation• Clinical assessment : Expanded Disability Status Scale (EDSS), ambulation test. Medications will be recorded. | Other | patient |
| Cognitive evaluation• Neuropsychological, psychological, social and social cognitive evaluation | Other | Control, patient |
Primary outcome
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)
3 secondary outcomes
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)
Correlation between measures of emotional processing and quality of life measures
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Results publication: PubMed 42622682Brochet B, Moreau T, Saubusse A, Charre-Morin J, Lamargue D, Deloire M, Ruet A. Episodic memory deficits are associated with social cognitive impairments in multiple sclerosis. J Neurol. 2026 Aug 20;273(9):534. doi: 10.1007/s00415-026-14067-7.
Related trials for Multiple Sclerosis
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 2
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruno BROCHET, Prof principal investigator
University Hospital, Bordeaux
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical evaluation and Cognitive evaluation in people with Multiple Sclerosis, run by University Hospital, Bordeaux at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interaction between measures of emotional processing (z score) and functional measures of social interaction (time frame: At inclusion (day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02708927, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.