Cognition and MRI Markers in MS Patients With Aubagio® Treatment
Everyday Life Cognition and Non-conventional Magnetic Resonance Markers in RRMS Patients Treated With Aubagio® in a Real-life Setting
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Clinical assessment
Given to everyone in the trial
- Ecological evaluation
- Neuropsychological evaluation
- Psychological evaluation
- MRI Evaluation
What it measured
Main measures
Change of composite z ecological score based on individual ecological scores.
At baseline (day 0) and at 24 months from baseline
Thinking and memory
Other measures (2)
Change of composite z cognitive score based on individual neuropsychological scores
At baseline (day 0) and at 24 months from baseline
Thinking and memoryCorrelation 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
MRI lesionsThinking and memoryNerve conduction tests
Who could take part
Relapsing MS · 18 to 60
Show the full criteria
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)
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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®.
Papers
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History
Started
May 2019
Main results due
Feb 2023
Finished
Feb 2023