Cognition and MRI Markers in MS Patients With Aubagio® Treatment

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®.

Conditions

• Multiple Sclerosis, Relapsing-Remitting

Interventions

OTHER

Clinical assessment

EDSS (Kurtzke JF; 1983) and the modified MS functional composite (MSFC) score. MS history and MS treatment will be recorded

OTHER

Ecological evaluation

Virtual reality task : Urban DailyCog© and Actual reality

OTHER

Neuropsychological evaluation

cognitive tests exploring information processing speed, attention/concentration, working and episodic memories and executive function

OTHER

Psychological evaluation

questionnaires for depression, anxiety and fatigue

DEVICE

MRI Evaluation

morphological MRI and resting state functional MRI (fMRI)

Sponsors & Collaborators

• Genzyme, a Sanofi Company

  collaborator INDUSTRY

• University Hospital, Bordeaux

  lead OTHER

Principal Investigators

• Aurélie RUET, Prof · University Hospital, Bordeaux

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-05-21

Primary Completion

2023-02-23

Completion

2023-02-23

Countries

• France

Study Locations