Active — Not RecruitingNot Applicable

OFSEP Very High Definition Cohort

France300 participantsStarted 2023-01-19

Plain-language summary

Multiple sclerosis (MS) is the most common acquired neurological disease leading to disability in young adults. MS often leads to the development of a physical and/or cognitive impairment that disables patients in their daily lives. Early use of disease modifying treatments for patients at risk of developing disability is therefore essential. However, disability progression is very heterogeneous between patients and currently impossible to predict at the individual level. Thus, numerous studies, particularly epidemiological and imaging studies, have identified prognostic factors for the development of disability such as age, gender, number of relapses during the first years of the disease, existence of a residual disability after a first relapse, number of gadolinium-enhancing lesions on initial MRI, early brainstem and spinal cord lesions. However, these different factors only explain incompletely the progression of the physical or cognitive disability in MS patients. In particular, some components of MS pathophysiology, more related to the progressive development of disability, such as axonal degeneration or the existence of chronic inflammation of the central nervous system (CNS) are usually not measured by these biomarkers. In this research project, the investigators will test promising biomarkers, focused on these components of the disease, on a large cohort of patients in a multicenter setting, in order to evaluate their added value to predict disability progression, in comparison with more classical biomarkers such as clinical characteristics, and brain and spinal cord lesion load. In particular, the investigators will test: * Imaging biomarkers extracted from brain and spinal cord MP2RAGE, brain and spinal cord QSM, brain and spinal cord relaxometry, brain diffusion and spinal cord magnetization transfer sequences * Biomarkers extracted from optical coherence tomography (OCT) * Biological biomarkers (serum neurofilament-light chain (NFL) and Glial Fibrillary Acidic Protein (GFAP))

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.

For MS patients: * Inclusion Criteria: * The patient must be already included in the OFSEP High Definition cohort (NCT03603457). * The patient must have given his informed and signed consent for the inclusion in the VHD cohort. * The patient must be insured or beneficiary of a health insurance plan. * Exclusion Criteria: * The patient is under judicial protection. * The patient refuses to sign the consent. * It is impossible to correctly inform the patient (Inability to understand the study, language problem). * The patient has experienced a relapse in the previous 3 months. * The patient is pregnant or breast-feeding (MRI contraindicated). * Patient with MRI contra-indications (patient with a pacemaker, ferromagnetic vascular clip, infusion pump, neurostimulator, cochlear implants or in whom there is a suspicion of a metallic foreign body). * The patient has a severe psychiatric illness * The patient has severe chronic alcoholism For healthy subjects: * Inclusion Criteria: * The healthy subject must be older than 18 years * The healthy subject must have given his informed and signed consent for the inclusion in the VHD cohort. * The healthy subject must be insured or beneficiary of a health insurance plan. * Exclusion Criteria: * The healthy subject is under judicial protection. * It is impossible to correctly inform the healthy subject (Inability to understand the study, language problem). * The healthy subject is pregnant or breast-…

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

Global disability progression

Timeframe: 2 years

Trial details

NCT IDNCT05622643

SponsorEDMUS Foundation

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-12-01

View on ClinicalTrials.gov More Multiple Sclerosis trials