Clinical trial NCT03455582: Cognition Evolution and MRI Markers in PPMS Patients on 2 Years
Official title: Longitudinal Study of Cognition in Primary Progressive Multiple Sclerosis: a Cohort Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Multiple Sclerosis, Primary Progressive
Keywords: cognitive impairment
ecological assessment
brain MRI
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
First posted: 2018-03-06
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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;
* 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).

Primary outcomes:
measure: Change of composite z cognitive score based on individual neuropsychological scores
timeFrame: At baseline (day 0) and at 24 months from baseline
Secondary outcomes:
measure: Correlation of composite z cognitive score and ecological score with MRI parameters reflecting grey and white matter integrity and anatomic/functional connectivity
timeFrame: At baseline (day 0) and at 24 months from baseline
measure: Change of composite z cognitive score based on individual neuropsychological scores
timeFrame: At baseline (day 0), at 12 months and at 24 months from baseline
measure: Changes of composite z ecological score based on individual ecological scores
timeFrame: At baseline (day 0), at 12 months and at 24 months from baseline
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Limoges
country: France
facility: CHU de Limoges
city: Poitiers
country: France
facility: CHU de Poitiers
Study officials:
affiliation: University Hospital, Bordeaux
name: Aurélie RUET, Prof
role: PRINCIPAL_INVESTIGATOR
References: