NCT03455582Completed
Cognition Evolution and MRI Markers in PPMS Patients on 2 Years
Longitudinal Study of Cognition in Primary Progressive Multiple Sclerosis: a Cohort Study
Source: ClinicalTrials.gov · Last updated 4 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 66 (actual)
- First submitted
- 4 Jan 2018
- Start date
- 24 Sept 2018
- Primary completion date
- 15 Apr 2026
- Lead sponsor
- University Hospital, Bordeaux
- Diseases
- Multiple sclerosis
- NCT number
- NCT03455582
What you commit to
- Study type: Interventional
- Participants enrolled: 66
- From 24 Sept 2018 to the primary completion date, 15 Apr 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- previous history of other neurological disease;
- change of psychotropic drug since less than one month;
- psychotropic drugs; known cognitive complaint or neuropsychological affection;
- prior neuropsychological testing with the same tests less than 6 months
Other illness
- psychiatric comorbidity including severe depression according to DSM-IV;
- 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);
- history of neurological disease;
- family history of MS;
- psychiatric comorbidity including severe depression according to DSM-IV;
- contra-indication to MRI (pacemakers, aneurysm clips, artificial heart valves, ear implants, meta fragments or foreign objects in the eyes, skin or body, claustrophobia or refusing MRI);
Lab values
- illiteracy, is unable to count or to read;
- illiteracy, is unable to count or to read;
Age
- 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
- person 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).
Other
- PATIENTS
- alcohol or other addiction to toxic;
- disabling visual or motor problems preventing participation to neuropsychological assessments;
- pregnant or breastfeeding women;
- alcohol or other toxic addiction;
- pregnant or breastfeeding women;
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU de Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| CHU de Limoges Coordinator of this site? Confirm its status | Limoges | France | Unknown status |
| CHU de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Unknown status |
Related publications
- Interthalamic adhesion alterations in multiple sclerosis: associations with thalamic damage and cognition.J Neurol · 2026 · PMID 42624921
This page is information, not medical advice. Discuss any trial with your doctor.