Longitudinal Study of Cognition in Primary Progressive Multiple Sclerosis: a Cohort Study
Overview
- Phase
- Not Applicable
- Intervention
- Clinical assessment
- Conditions
- Multiple Sclerosis, Primary Progressive
- Sponsor
- University Hospital, Bordeaux
- Enrollment
- 66
- Locations
- 3
- Primary Endpoint
- Change of composite z cognitive score based on individual neuropsychological scores
- Status
- Active, not recruiting
- Last Updated
- 2 months ago
Overview
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 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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;
Exclusion Criteria
- •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
Arms & Interventions
patient
PPMS diagnosis according to McDonald 2010 criteria (Polman et al, 2011)
Intervention: Clinical assessment
patient
PPMS diagnosis according to McDonald 2010 criteria (Polman et al, 2011)
Intervention: Ecological evaluation
patient
PPMS diagnosis according to McDonald 2010 criteria (Polman et al, 2011)
Intervention: Neuropsychological evaluation
patient
PPMS diagnosis according to McDonald 2010 criteria (Polman et al, 2011)
Intervention: Psychological evaluation
patient
PPMS diagnosis according to McDonald 2010 criteria (Polman et al, 2011)
Intervention: MRI Evaluation
Control
40 Healthy controls
Intervention: Ecological evaluation
Control
40 Healthy controls
Intervention: Neuropsychological evaluation
Control
40 Healthy controls
Intervention: Psychological evaluation
Control
40 Healthy controls
Intervention: MRI Evaluation
Outcomes
Primary Outcomes
Change of composite z cognitive score based on individual neuropsychological scores
Time Frame: At baseline (day 0) and at 24 months from baseline
The composite z cognitive score is the average of z individual cognitive scores. The score from each cognitive test is transformed into z-scores. Z-scores will be calculated for each cognitive score with the following formula: (patient's score - mean value of HC group matched for age, sex, and education level)/standard deviation of the matched HC for each evaluation time (baseline and 2 years). Individual neuropsychological scores included in composite z cognitive score : the Alertness subtest, the divided attention subtest and the visual-scanning subtest from the TAP, The Symbol-digit-modalities-test, the Paced-Auditory-Serial-Addition-Test 3s, reversed span, the Stroop test, the Verbal fluency, Trail Making test, the California Verbal memory learning test and the Brief visual memory test -revised
Secondary Outcomes
- Changes of composite z ecological score based on individual ecological scores(At baseline (day 0), at 12 months and at 24 months from baseline)
- Change of composite z cognitive score based on individual neuropsychological scores(At baseline (day 0), at 12 months and at 24 months from baseline)
- Correlation of composite z cognitive score and ecological score with MRI parameters reflecting grey and white matter integrity and anatomic/functional connectivity(At baseline (day 0) and at 24 months from baseline)