Cognition and MRI Markers in MS Patients With Aubagio® Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-21

Study Completion Date

2023-02-23

Brief Summary

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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®.

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Detailed Description

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Conditions

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Multiple Sclerosis, Relapsing-Remitting

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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patient

RRMS diagnosis according to McDonald criteria (Polman et al.,2005);

Group Type EXPERIMENTAL

Clinical assessment

Intervention Type OTHER

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

Ecological evaluation

Intervention Type OTHER

Virtual reality task : Urban DailyCog© and Actual reality

Neuropsychological evaluation

Intervention Type OTHER

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

Psychological evaluation

Intervention Type OTHER

questionnaires for depression, anxiety and fatigue

MRI Evaluation

Intervention Type DEVICE

morphological MRI and resting state functional MRI (fMRI)

Control

40 Healthy controls (HC)

Group Type ACTIVE_COMPARATOR

Ecological evaluation

Intervention Type OTHER

Virtual reality task : Urban DailyCog© and Actual reality

Neuropsychological evaluation

Intervention Type OTHER

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

Psychological evaluation

Intervention Type OTHER

questionnaires for depression, anxiety and fatigue

MRI Evaluation

Intervention Type DEVICE

morphological MRI and resting state functional MRI (fMRI)

Interventions

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Clinical assessment

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

Intervention Type OTHER

Ecological evaluation

Virtual reality task : Urban DailyCog© and Actual reality

Intervention Type OTHER

Neuropsychological evaluation

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

Intervention Type OTHER

Psychological evaluation

questionnaires for depression, anxiety and fatigue

Intervention Type OTHER

MRI Evaluation

morphological MRI and resting state functional MRI (fMRI)

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes