Everyday Life Cognition and Non-conventional Magnetic Resonance Markers in RRMS Patients Treated With Aubagio® in a Real-life Setting
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Sponsor
- University Hospital, Bordeaux
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Change of composite z ecological score based on individual ecological scores.
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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®.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Change of composite z ecological score based on individual ecological scores.
Time Frame: At baseline (day 0) and at 24 months from baseline
The composite z ecological score is the average of z ecological scores of virtual reality task (Urban DailyCog©) and actual reality tests. 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).
Secondary Outcomes
- Change of composite z cognitive score based on individual neuropsychological scores(At baseline (day 0) 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)