Status:
ACTIVE_NOT_RECRUITING
Cognition Evolution and MRI Markers in PPMS Patients on 2 Years
Lead Sponsor:
University Hospital, Bordeaux
Collaborating Sponsors:
Roche Pharma AG
Conditions:
Multiple Sclerosis, Primary Progressive
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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;
- psychotropic drugs; known cognitive complaint or neuropsychological affection;
- prior neuropsychological testing with the same tests less than 6 months
- 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);
- illiteracy, is unable to count or to read;
- pregnant or breastfeeding women;
- 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).
Key Trial Info
Start Date :
September 24 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2026
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT03455582
Start Date
September 24 2018
End Date
March 1 2026
Last Update
February 20 2025
Active Locations (3)
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1
CHU de Bordeaux
Bordeaux, France
2
CHU de Limoges
Limoges, France
3
CHU de Poitiers
Poitiers, France