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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A02785-50 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| Genzyme, a Sanofi Company | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patient | Experimental | RRMS diagnosis according to McDonald criteria (Polman et al.,2005); |
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| Control | Active Comparator | 40 Healthy controls (HC) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical assessment | Other | EDSS (Kurtzke JF; 1983) and the modified MS functional composite (MSFC) score. MS history and MS treatment will be recorded |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of composite z ecological score based on individual ecological scores. | The composite z ecological score is the average of z ecological scores of virtual reality task (Urban DailyCog©) and actual reality tests. Z-scores will be calculated for each cognitive score with the following formula: (patient's score - mean value of HC group matched for age, sex, and education level)/standard deviation of the matched HC for each evaluation time (baseline and 2 years). | At baseline (day 0) and at 24 months from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Change of composite z cognitive score based on individual neuropsychological scores | The composite z cognitive score is the average of z individual cognitive scores. The score from each cognitive test is transformed into z-scores. Z-scores will be calculated for each cognitive score with the following formula: (patient's score - mean value of HC group matched for age, sex, and education level)/standard deviation of the matched HC for each evaluation time. Individual neuropsychological scores included in composite z cognitive score : the Alertness subtest, the divided attention subtest and the visual-scanning subtest from the TAP, The Symbol-digit-modalities-test, the Paced-Auditory-Serial-Addition-Test 3s, reversed span, the Stroop test, the Verbal fluency, Trail Making test, the California Verbal memory learning test and the Brief visual memory test -revised. |
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Inclusion Criteria:
PATIENTS
HEALTHY CONTROLS
Exclusion Criteria:
PATIENTS
HEALTHY CONTROLS
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| Name | Affiliation | Role |
|---|---|---|
| Aurélie RUET, Prof | University Hospital, Bordeaux | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Bordeaux - Service de neurologie | Bordeaux | France |
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| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| D020274 | Autoimmune Diseases of the Nervous System |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D003711 | Demyelinating Diseases |
| D007154 | Immune System Diseases |
| D009422 | Nervous System Diseases |
| D010335 | Pathologic Processes |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D001327 | Autoimmune Diseases |
| D056784 | Leukoencephalopathies |
| D001927 | Brain Diseases |
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| Ecological evaluation | Other | Virtual reality task : Urban DailyCog© and Actual reality |
|
| Neuropsychological evaluation | Other | cognitive tests exploring information processing speed, attention/concentration, working and episodic memories and executive function |
|
| Psychological evaluation | Other | questionnaires for depression, anxiety and fatigue |
|
| MRI Evaluation | Device | morphological MRI and resting state functional MRI (fMRI) |
|
| At baseline (day 0) and at 24 months from baseline |
| Correlation of composite z cognitive score and ecological score with MRI parameters reflecting grey and white matter integrity and anatomic/functional connectivity | The composite z cognitive score and the composite ecological score are the average of z individual cognitive and ecological scores. The score from each cognitive and ecological test is transformed into z-scores. Z-scores will be calculated for each cognitive score with the following formula: (patient's score - mean value of HC group matched for age, sex, and education level)/standard deviation of the matched HC for each evaluation time. | At baseline (day 0) and at 24 months from baseline |
| D002493 |
| Central Nervous System Diseases |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |