CompletedNot Applicable

Study of Social Cognition by Morphological and Functional Imaging in Multiple Sclerosis Patients

France35 participantsStarted 2015-11

Plain-language summary

In recent years, studies have brought knowledge of the difficulties of social cognition in Multiple Sclerosis (MS). The brain tissue alteration at the origin of these difficulties in social cognition mechanisms remain poorly understood. Although recent behavioral studies indicated social disturbances in many of these patients, functional studies investigating specific theory of mind in MS are lacking. The use of new techniques for morphological and functional Magnetic Resonance Imaging (MRI) can identify brain activation networks, mapping the achievement and tissue integrity may be related to disorders of social cognition and cognitive. The investigators propose to study social cognition in MS patients using morphological and functional imaging to determine the mechanisms underlying phenomena such as cerebral compensation and its relationship with cognitive impairment.

Who can participate

Age range

18 Years – 59 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria (patient group): * Aged 18-59 years * Right handed * Fluent French speaker * MS diagnosis according to McDonald criteria (Polman et al., 2005). * Relapsing-remitting MS (RRMS) according to Lublin et al. (1996); * Having signed an informed consent (later than the day of inclusion and before any examination required by research) * Being affiliated to health insurance Inclusion Criteria (healthy control): * Aged 18-59 years * Right handed * Fluent French speaker * Having signed an informed consent (later than the day of inclusion and before any examination required by research) * Being affiliated to health insurance 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, * Expanded Disability Status Scale (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 one month, * Contra-indication to MRI (pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body, claustrophobia) or refusing MRI * Illiteracy, is unable to count or to read * Pregnant or breastfeeding women * Being under guardianship Exclusion Criteria (healthy control): * History of neurologica…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Brain activation networks during MRI

Timeframe: At inclusion (day 0)

Trial details

NCT IDNCT02290587

SponsorUniversity Hospital, Bordeaux

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-03

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