CompletedNot Applicable

Cognition Evolution and MRI Markers in PPMS Patients on 2 Years

France66 participantsStarted 2018-09-24

Plain-language summary

Cognitive impairment is nowadays more and more recognized as an important feature of the multiple sclerosis (MS) disease. Cognitive disorders frequency in MS is estimated between 40 and 60%. Cognitive impairment affects quality of life and vocational status in MS patients. Until recently, little information was available on the cognitive dysfunction and their evolution that occur in primary progressive multiple sclerosis (PPMS) as compared with relapsing-remitting MS (RRMS). In PPMS pathological studies have shown the importance of cortical demyelination and meningeal inflammation suggesting that the GM alteration could play a major role in the cognitive impairment in this phenotype. The cognitive evolution and the brain tissue alteration at the origin of these difficulties remain poorly understood in PPMS. The use of new techniques for morphological and functional MRI can study the contribution of diffuse White Matter (WM) alteration (probably through disconnexion of relevant network) and diffuse Grey matter (GM) alterations in the cerebral cortex and other structures (the hippocampi, the cerebellum, and the thalami) in cognitive impairment in PPMS patients and on their evolution.

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: PATIENTS * Male or female; * Age ≥ 18 years; * PPMS diagnosis according to McDonald 2010 criteria; * Disease duration ≤ 15 years; * Native French speaking; * Being affiliated to health insurance; * Willing to participate and to sign informed consent. HEALTHY CONTROLS * Male or Female; * Age ≥ 18 years; * Native French speaking; * Being affiliated to health insurance; * Willing to participate and to sign informed consent. Exclusion Criteria: PATIENTS * previous history of other neurological disease; * 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; * change of 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; * patient concerned by articles L 1121-5 to L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent). HEALTHY CONTROLS * history of neurological disease; * family history of MS; * psychiatric comorbidity including severe depression according to DSM-IV; * alcohol or other toxic addiction…

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?

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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 cognitive score based on individual neuropsychological scores

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

Trial details

NCT IDNCT03455582

SponsorUniversity Hospital, Bordeaux

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-15

View on ClinicalTrials.gov More Multiple Sclerosis, Primary Progressive trials