Serum Neurofilaments and GFAP in Atypical Multiple Sclerosis (NCT04201470) | Clinical Trial Compass
CompletedNot Applicable
Serum Neurofilaments and GFAP in Atypical Multiple Sclerosis
France58 participantsStarted 2019-12-09
Plain-language summary
Idiopathic inflammatory disorders of the central nervous system include various disorders of which multiple sclerosis is the most common. Besides multiple sclerosis, other distinct disorders including for example anti-AQP4 (aquaporine-4) and anti-MOG (Myelin oligodendrocyte glycoprotein) NMOSD (Neuromyelitis optica spectrum disorder) have been well characterized and are now known to be distinct from MS.
some patient belonging to MS spectrum have recently being characterized but unusual MRI findings have mimicking inherited leukoencephalopathies and leukodystrophies.
Whether these patients with atypical phenotype represent a separate disease distinct from MS or belong to MS spectrum is not clear.
The objectives are to evaluate a series of 15 patients with atypical forms of MS using non-conventional MRI techniques and biological biomarkers (serum neurofilaments light chain) and to compare them with classical MS patients (15 relapsing remitting patients and 15 progressive patients) and 15 controls. the hypothesize is that these patients with atypical MS have a more severe neurodegenerative process.
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:
* The subject must have given his informed consent and signed the consent form (if patient is protected by the law due to the study pathology, the consent will be signed his tutor or guardian ; if patient is unable to read or sign the consent form due to the study pathology, the consent will be signed by his family/trusted person)
* The subject is at least 18 years old (≥).
* Affiliate or beneficiary of a social security scheme
Inclusion criteria specific to Patients:
* Patients with atypical form of MS
* OR patients with RRMS (Relapsing-Remitting Multiple Sclerosis)
* OR patients with PPMS (Primary Progressive Multiple Sclerosis)
(Patients will be matched on EDSS score (+/-1) and age (+/-5) ; Controls will be matched with patients on age)
Exclusion Criteria:
* Pregnant or lactating women.
* Vulnerable people.
* Simultaneous participation in any other research protocol.
* Contraindication to the realization of an MRI (ferromagnetic ocular or cerebral foreign bodies close to nerve structures, pace-maker, cochlear implants)
* Claustrophobic subject
* Subject presenting a neurodegenerative disease (Parkinson, Alzheimer ...)
* Subject presenting psychiatric disorders like psychosis, excluding anxio-depressive episode
* Subject presenting a systemic pathology with neurological manifestation
* Subject presenting anterior or evolutionary neurological pathology other than the 3 entities defined in the inclusion criteria
* Subject presenting or having had a h…
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.