CompletedNot Applicable

Cognition and MRI Markers in MS Patients With Aubagio® Treatment

France75 participantsStarted 2019-05-21

Plain-language summary

Cognitive impairment is nowadays more and more recognized as an important feature of the multiple sclerosis (MS) disease which contributes largely to disability. Cognitive assessment using classical neuropsychological tests are poorly correlated with patient's complaints and daily functioning. Ecological evaluations, recent and innovative way to assess cognitive functions with the true impact of cognitive impairment in everyday daily life of patients. One goal of an ecological test could be to identify MS patients in whom cognitive impairment has a strong interaction with daily life. Different type of ecological evaluation have been recently proposed in MS, including assessment cognitive tasks in a virtual reality environment using the Urban DailyCog® software developed in our laboratory (Hamel et al, 2015). Virtual reality environment assessments are promising in detecting cognitive impairment while providing friendly assessments for patients and simulating daily activities. . Cognitive dysfunction is correlated with white matter diffuse injury in relapsing-remitting MS (RRMS) patients and brain atrophy However, the relationships between structural brain damage and brain connectivity with cognitive functioning assessed by ecological evaluation are also unknown. The use of new techniques for morphological and functional MRI can study the contribution of diffuse white matter (WM) alteration and diffuse gray matter (GM) alterations in cognitive impairment and on their evolution. The objectives are to evaluate the ecological assessment (Urban DailyCog® and actual reality) to detect cognitive impairment in everyday daily life of patients and their changes and to investigate structural WM and GM damages and the dynamic of functional connectivity for explaining and predicting cognitive disability during two years in RRMS patients treated by the same treatment Aubagio®.

Who can participate

Age range

18 Years – 60 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: PATIENTS * Male or female * Age 18-60 years * RRMS diagnosis according to McDonald criteria (Polman et al., 2005); * Treated with Aubagio® (Indication for first line therapy) * Native French speaking * Being affiliated to health insurance * Having signed an informed consent (at the latest on the day of inclusion and before any examination required by research) HEALTHY CONTROLS * Male or Female, * Age 18-60 years * Willing to participate and to sign informed consent. * Being affiliated to health insurance * Having signed an informed consent (at the latest on the day of inclusion and before any examination required by research) Exclusion Criteria: PATIENTS * History of neurological disease and/or other neurological diseases, * Psychiatric comorbidity including severe depression according to DSM-IV, * Alcohol or other addiction to toxic, * Disabling visual or motor problems preventing participation to neuropsychological assessments, * Acquisition disorders : Dyslexia, Dysphasia, Dyscalculia and dyspraxia, * Dosage change, stop or start of hypnotic or anxiolytic or antidepressive treatment less than 30 days * Relapse since less than one month, * Steroid treatment less than one month (be taken orally or by infusion) at the dosage of 500mg daily, * Prior neuropsychological testing with the same tests less than 6 months * Contra-indication to MRI (pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the e…

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

Change of composite z ecological score based on individual ecological scores.

Timeframe: At baseline (day 0) and at 24 months from baseline

Trial details

NCT IDNCT03768648

SponsorUniversity Hospital, Bordeaux

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-02-23

View on ClinicalTrials.gov More Multiple Sclerosis, Relapsing-Remitting trials