Not Yet RecruitingNot Applicable

MS and Health Cohort

2,000 participantsStarted 2026-06-11

Plain-language summary

This study aims to identify clinical, biological, imaging, and environmental factors that predict the progression and severity of Multiple Sclerosis (MS). We will establish a prospective, highly phenotyped cohort of patients diagnosed with MS according to the 2024 criteria, regardless of disease form or stage. We hypothesize that combining neurological, vascular, metabolic, neuropsychological, environmental, and imaging data (from the central nervous system and the eye) will improve the identification of markers associated with MS progression. This integrative approach will help clarify the respective roles of inflammation, vascular dysfunction, myelin repair, and neurodegeneration in disability accumulation. The study will also evaluate the impact of MS, disability, and treatments on patients' physical, mental, and social health, as defined by the World Health Organization (WHO). These results are expected to support personalized patient management and identify modifiable risk factors to reduce disability and inform future therapeutic strategies. The primary objective is to identify factors that worsen neurological disability in MS patients, including disease-related, comorbidity, and environmental factors. The main outcome measure is time to confirmed disability accumulation (CDA), defined as an increase in the EDSS (Expanded Disability Status Scale) score confirmed after at least 3 months. This single-center, 5-year prospective cohort study will be conducted at Hôpital Fondation Adolphe de Rothschild (Paris, France), with annual visits. A linkage with national health data (SNDS) will be established for both MS patients and a matched control group (5:1 ratio). Additional research procedures include: Ophthalmologic exams (OCT, angio-OCT, fundus photography, pupillometry) at baseline, year 1, 3, and 5. Brain MRI with additional non-contrast research sequences (annual). Clinical assessments including arterial stiffness and hearing tests. Blood sampling (up to 40 mL) for biomarker analyses and long-term biobanking (25 years). Lumbar puncture if clinically indicated at baseline (with extra samples for research). Physical activity and circadian rhythm monitoring using a wrist accelerometer for 9 consecutive days. Standardized questionnaires assessing quality of life, education, and social/professional impact. Inclusion criteria: Age ≥ 18 years Diagnosis of MS according to 2024 criteria

Who can participate

Age range

18 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: * Age ≥ 18 years. * Multiple sclerosis defined according to the 2024 criteria. * Participant affiliated with or beneficiary of a social security system, Universal - -- Health Coverage (CMU), or any equivalent healthcare coverage scheme. * Written informed consent. Exclusion Criteria: * Pregnant or breastfeeding women. * Progressive disease with a life expectancy of less than one year. * Inability to undergo MRI * Person refusing to be informed of any clinically significant finding concerning their health discovered during participation in the study. * Patient impairment making participation in the study or understanding of the - information provided difficult or impossible. * Person under legal protection measures (guardianship, curatorship, or judicial protection). * Person deprived of liberty by judicial or administrative decision.

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

Confirmed disability accumulation (CDA)

Timeframe: 5 years

Trial details

NCT IDNCT07645703

SponsorFondation Ophtalmologique Adolphe de Rothschild

Sponsor typeNETWORK

Study typeOBSERVATIONAL

Primary completion2034-06

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