NCT03768648: AUBACOG

Cognition and MRI Markers in MS Patients With Aubagio® Treatment

Completed NA Last updated 8 March 2023

What this trial tests

NA trial testing Clinical assessment in Multiple Sclerosis, Relapsing-Remitting in 75 participants. Completed in 23 February 2023.

Timeline

21 May 2019

Primary endpoint
23 February 2023

23 February 2023

Quick facts

Lead sponsor	University Hospital, Bordeaux
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	75
Start date	21 May 2019
Primary completion	23 February 2023
Estimated completion	23 February 2023
Sites	1 location across France

Drugs / interventions tested

• Clinical assessment — full drug profile →
• Ecological evaluation
• Neuropsychological evaluation
• Psychological evaluation
• MRI Evaluation

Conditions studied

• Multiple Sclerosis, Relapsing-Remitting — all drugs for Multiple Sclerosis, Relapsing-Remitting →

Sponsor

University Hospital, Bordeaux

Who can join

Adults 18 to 60, any sex, with Multiple Sclerosis, Relapsing-Remitting. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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®.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.