Study of Empathy in MS

NCT05332951 | Completed

• 2 other identifiers: APHP2202412022-A00713-40
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

Multiple sclerosis is a chronic inflammatory disease of the central nervous system whose exact etiology remains unclear, underpinned by multiple pathophysiological mechanisms, and is a cause of significant motor and cognitive disability. Some studies report a prevalence of 40% to 60% of cognitive impairment during the disease, and represents a major factor influencing quality of life in patients with MS. Cognitive impairment can affect one or more of the 6 cognitive functions, including social cognition and its three components: theory of mind, or an individual's ability to infer intention and other's behavior, empathy, and social perceptions and knowledge. To date, few studies have focused on the more specific study of empathy in MS. They seem to suggest the existence of a deficit but rely on small numbers of patients. There appear to be many confounding factors but their direct relationship to empathy is not clearly established: potentially related comorbidities, such as anxiety and depression that are frequently found in MS patients ; level of education and cognitive reserve; and finally the very characteristics of the disease. Indeed, data concerning relationship between empathy and the activity or stage of MS seem so far contradictory. Alexithymia, or inability to express feelings verbally, is a pathology close to empathy deficit, and can affect patients' daily lives in a similar way. Prevalence of alexithymia in MS patients has been shown to be higher than in general population, and its parallel study with empathy seems relevant. The aim of this study is to assess the level of empathy on a larger scale of MS population and to study various confounding factors known to influence the level of empathy, such as anxiety, depression, level of education but also the characteristics of the disease: its duration of evolution, its stage, its activity, and associated disability. The investigator team will conduct a prospective observational study in MS patients to assess their level of empathy versus a control population of healthy subjects and study the influence of these different variables.

Conditions

Multiple Sclerosis

Keywords

MS; social cognition; empathy

Outcome Measures

Primary Outcomes (1)

• Interpersonal Reactivity Index (IRI)

  QUestionnaire IRI will be completed by patients

  5 minutes

Secondary Outcomes (5)

• alexithymia

  5 minutes

• anxiety and depression

  5 minutes

• cognitive reserve

  5 minutes

• fatigue

  5 minutes

• cognitive deficit

  3 minutes

Study Arms (1)

Adult patients followed for multiple sclerosis

Other: Interpersonal Reactivity Index

Interventions

Interpersonal Reactivity Index OTHER

Questionnaire to be completed by the patient

Adult patients followed for multiple sclerosis

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients followed for multiple sclerosis

You may qualify if:

• Patient aged 18 to 60
• Follow-up for multiple sclerosis meeting the revised McDonalds diagnostic criteria of 2017.
• Patient not objecting to participation in the research.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (2)

Hôpital de la Pitié Salpêtrière

Paris, France

Location

Hôpital Saint Antoine

Paris, France

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: April 18, 2022
• Study Start: July 4, 2022
• Primary Completion: December 19, 2022
• Study Completion: December 19, 2022
• Last Updated: February 2, 2024

Record last verified: 2024-01

Locations

FR (2)