Everyday Life Cognition and Non-conventional Magnetic Resonance Markers in RRMS Patients Treated With Aubagio® in a Real-life Setting

Who is this study for? Patients with Multiple Sclerosis
What treatments are being studied? Clinical Assessment
Status: Completed
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: t
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⁃ 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)

Locations
Other Locations
France
CHU de Bordeaux - Service de neurologie
Bordeaux
Time Frame
Start Date: 2019-05-21
Completion Date: 2023-02-23
Participants
Target number of participants: 75
Treatments
Experimental: patient
RRMS diagnosis according to McDonald criteria (Polman et al.,2005);
Active_comparator: Control
40 Healthy controls (HC)
Sponsors
Collaborators: Genzyme, a Sanofi Company
Leads: University Hospital, Bordeaux

This content was sourced from clinicaltrials.gov