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| Name | Class |
|---|---|
| University Hospital, Bordeaux | OTHER |
| University Hospital, Caen | OTHER |
| University Hospital, Marseille | OTHER |
| Dr Remy MORELLO - CHU de Caen |
Multiple Sclerosis is the first cause of neurological handicap in France. The importance of cognitive disabilities, their evaluation and their impact on patients' life have only been comprehended recently. Immunosuppressants represent new treatments in Multiple Sclerosis (MS) but imply a lot of constraints. This study will evaluate the impact of these treatments on cognitive disabilities, tiredness state, emotion and quality of life in general, on a lengthened period.
Multiple Sclerosis is the first cause of neurological handicap in France. The importance of cognitive disabilities, their evaluation and their impact on patients' life have only been comprehended recently. Immunosuppressants represent new treatments in MS but imply a lot of constraints. This study will evaluate the impact of these treatments on cognitive disabilities, tiredness state, emotion and quality of life in general, on a lengthened period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sclerosis | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuropsychological assessment | Other | This study will evaluate the impact of these treatments on cognitive disabilities, tiredness state, emotion and quality of life in general, on a lengthened period. |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of the quality of life of patients diagnosed with relapsing MS and starting a treatment with immunosuppressant | on a 36 months period |
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of variance for repeated measurement | 15 to 30 days before the beginning of treatment, after 36 months | |
| Selective Reminding Test (SRT) | 15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pierre CLAVELOU | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont-Ferrand | Clermont-Ferrand | 63003 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29111011 | Derived | Planche V, Moisset X, Morello R, Dumont E, Gibelin M, Charre-Morin J, Saubusse A, Mondou A, Reuter F, Defer G, Pelletier J, Brochet B, Clavelou P. Improvement of quality of life and its relationship with neuropsychiatric outcomes in patients with multiple sclerosis starting treatment with natalizumab: A 3-year follow-up multicentric study. J Neurol Sci. 2017 Nov 15;382:148-154. doi: 10.1016/j.jns.2017.10.008. Epub 2017 Oct 6. |
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| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D009483 | Neuropsychological Tests |
| ID | Term |
|---|---|
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
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| UNKNOWN |
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| Delayed recall of SRT | 15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months |
| Visuo-spatial span | 15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months |
| Digit span | 15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months |
| Reverse span | 15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months |
| Stroop test | 15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months |
| • Tiredness (EMIF SEP scale): Analysis of variance for repeated measurement | 15 to 30 days before the beginning of treatment, 1st day of treatment, after 6,12,18 and 36 months |
| • Physical function (9HPT, 8 meter walk) : Analysis of variance for repeated measurement | 15 to 30 days before the beginning of treatment, 1st day of treatment, after 6,12,18 and 36 months |
| Disability (EDSS) : Analysis of variance for repeated measurement | 15 to 30 days before the beginning of treatment, 1st day of treatment, after 6,12,18 and 36 months |
| • Psychological disorder (Beck depression inventory, COVI scale, Depressive scale) : Analysis of variance for repeated measurement | 15 to 30 days before the beginning of treatment, 1st day of the treatment, after 6,12,18 and 36 months |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |