Clinical trial NCT03768648: Cognition and MRI Markers in MS Patients With Aubagio® Treatment
Official title: Everyday Life Cognition and Non-conventional Magnetic Resonance Markers in RRMS Patients Treated With Aubagio® in a Real-life Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
cognitive impairment
ecological assessment
brain MRI
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Genzyme, a Sanofi Company
First posted: 2018-12-07
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: 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 which contributes largely to disability. Cognitive assessment using classical neuropsychological tests are poorly correlated with patient's complaints and daily functioning. Ecological evaluations, recent and innovative way to assess cognitive functions with the true impact of cognitive impairment in everyday daily life of patients. One goal of an ecological test could be to identify MS patients in whom cognitive impairment has a strong interaction with daily life. Different type of ecological evaluation have been recently proposed in MS, including assessment cognitive tasks in a virtual reality environment using the Urban DailyCog® software developed in our laboratory (Hamel et al, 2015). Virtual reality environment assessments are promising in detecting cognitive impairment while providing friendly assessments for patients and simulating daily activities. . Cognitive dysfunction is correlated with white matter diffuse injury in relapsing-remitting MS (RRMS) patients and brain atrophy However, the relationships between structural brain damage and brain connectivity with cognitive functioning assessed by ecological evaluation are also unknown. The use of new techniques for morphological and functional MRI can study the contribution of diffuse white matter (WM) alteration and diffuse gray matter (GM) alterations in cognitive impairment and on their evolution.

The objectives are to evaluate the ecological assessment (Urban DailyCog® and actual reality) to detect cognitive impairment in everyday daily life of patients and their changes and to investigate structural WM and GM damages and the dynamic of functional connectivity for explaining and predicting cognitive disability during two years in RRMS patients treated by the same treatment Aubagio®.


Eligibility criteria: Inclusion Criteria:

PATIENTS

* Male or female
* Age 18-60 years
* RRMS diagnosis according to McDonald criteria (Polman et al., 2005);
* Treated with Aubagio® (Indication for first line therapy)
* Native French speaking
* Being affiliated to health insurance
* Having signed an informed consent (at the latest on the day of inclusion and before any examination required by research)

HEALTHY CONTROLS

* Male or Female,
* Age 18-60 years
* Willing to participate and to sign informed consent.
* Being affiliated to health insurance
* Having signed an informed consent (at the latest on the day of inclusion and before any examination required by research)

Exclusion Criteria:

PATIENTS

* History of neurological disease and/or other neurological diseases,
* 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,
* Acquisition disorders : Dyslexia, Dysphasia, Dyscalculia and dyspraxia,
* Dosage change, stop or start of hypnotic or anxiolytic or antidepressive treatment less than 30 days
* Relapse since less than one month,
* Steroid treatment less than one month (be taken orally or by infusion) at the dosage of 500mg daily,
* Prior neuropsychological testing with the same tests less than 6 months
* 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 and/or neurological diseases
* Psychiatric comorbidity including severe depression according to DSM-IV;
* Alcohol or other toxic addiction;
* Known cognitive complaint or neuropsychological affection
* Hypnotic or anxiolytic or antidepressive treatment,
* Prior neuropsychological testing with the same tests less than 6 months
* Acquisition disorders: Dyslexia, Dysphasia, Dyscalculia and dyspraxia,
* Steroid treatment less than one month (be taken orally or by infusion) at the dosage of 500mg daily,
* 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
* 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 ecological score based on individual ecological scores.
timeFrame: At baseline (day 0) and at 24 months from baseline
Secondary outcomes:
measure: Change of composite z cognitive score based on individual neuropsychological scores
timeFrame: At baseline (day 0) and at 24 months from baseline
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
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux - Service de neurologie
Study officials:
affiliation: University Hospital, Bordeaux
name: Aurélie RUET, Prof
role: PRINCIPAL_INVESTIGATOR
References: