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Without the participation of people with MS, it would be impossible to develop new and better therapies and other interventions.
Study of Empathy in MS
Study Purpose
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.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Observational |
Eligible Ages | 18 Years - 60 Years |
Gender | All |
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT05332951 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
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Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Assistance Publique - Hôpitaux de Paris |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
N/A |
Principal Investigator Affiliation | N/A |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other |
Overall Status | Not yet recruiting |
Countries | |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Multiple Sclerosis |
Contact Information
This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:
Benedetta BODINI, MD, PH
For additional contact information, you can also visit the trial on clinicaltrials.gov.
Posting a Trial
If you would like us to post a study on these pages, please email studies@nmss.org to find out what information you need to submit for review.