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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-A01646-41 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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Cognitive disorders are common in early stage of Multiple Sclerosis (MS) and concern mainly information processing speed (IPS) which also influences with other cognitive functions such as attention, working memory and executive functions. The investigators validated a computerized test of IPS, the computerized speed cognitive test (CSCT), which can detect disorders of IPS in MS. A short battery was proposed, the brief cognitive assessment for multiple sclerosis (BICAMS) battery, which combines the Symbol-Digit Modalities-test (SDMT), a test of the IPS, and two measures of episodic memory. On the same principle, the investigators propose to validate a short computerized battery to improve the feasibility (brief computerized cognitive assessment (BCCAMS)) combining the CSCT and a computerized test of visual episodic memory.
Purpose: to establish the screening value of a brief computerized cognitive assessment (BCCAMS) combining the computerized speed cognitive test (CSCT) and a new computerized episodic visual memory test (CEVMT) in French-speaking patients with multiple sclerosis as compared to a reference battery (MACFIMS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient | Experimental | MS Relapsing-remitting under interferon beta-1b treatment in inclusion, Secondary progressive and Primary progressive MS forms |
|
| Control | Experimental | healthy subject |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive evaluation | Behavioral |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Prediction by the z score BCCAMS of cognitive impairment (at least two tests MACFIMS battery <1.5 SD of control subjects | average z scores of CEVMT and CSCT | At the inclusion (Day 0) |
| Measure | Description | Time Frame |
|---|---|---|
| Determine values of neuropsychological tests in healthy according to age subjects, gender and the level education | BCCAMS and MACFIMS | At the inclusion (Day 0) and at 1 and 6 months after the inclusion (Day 0) |
| Ability of the CEVMT to detect episodic memory deficiencies in patients with multiple sclerosis, as compared to established tests of episodic memory |
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Inclusion Criteria:
Patients :
Controls:
Exclusion Criteria:
Patients:
Controls:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Bordeaux | Bordeaux | 33000 | France | |||
| CHU de Caen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29462665 | Result | Ruet A, Brochet B. Cognitive assessment in patients with multiple sclerosis: From neuropsychological batteries to ecological tools. Ann Phys Rehabil Med. 2020 Mar;63(2):154-158. doi: 10.1016/j.rehab.2018.01.006. Epub 2018 Feb 17. | |
| 32713736 | Result | Maubeuge N, Deloire MSA, Brochet B, Erhle N, Charre-Morin J, Saubusse A, Ruet A; BICAFMS study investigators. French validation of the Brief International Cognitive Assessment for Multiple Sclerosis. Rev Neurol (Paris). 2021 Jan-Feb;177(1-2):73-79. doi: 10.1016/j.neurol.2020.04.028. Epub 2020 Jul 23. |
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| Expanded Disability Status Scale (EDSS) score | Behavioral | - EDSS score |
|
California verbal learning test-II and brief-visual memory test-revised |
| At the inclusion (Day 0) and at 1 and 6 months after the inclusion (Day 0) |
| Correlation between alternate forms of the CEVMT and the Brief visual memory test-revised (BVMT-R) | congnitive test | At the inclusion (Day 0) and at 1 and 6 months after the inclusion (Day 0) |
| Prediction between cognitive impairment and occupational status/leisure activities | questionnaire | At the inclusion (Day 0) and 6 months after the inclusion (Day 0) |
| Effect of possible confounders on results of cognitive testing, including depression, mood, anxiety and fatigue | scale | At the inclusion (Day 0) and at 1 and 6 months after the inclusion (Day 0) |
| Reproducibility of CSCT, CEVMT and the symbol-digit modalities test in clinical settings in patients with multiple sclerosis | congnitive test | At 1 and 6 months after the inclusion (Day 0) |
| Caen |
| 14033 |
| France |
| CHU de Clermont-Ferrand | Clermont-Ferrand | 63003 | France |
| Hôpital du Bocage | Dijon | 21079 | France |
| CH de Dunkerque | Dunkirk | 59385 | France |
| Centre Hospitalier Saint Vincent de Paul | Lille | 59020 | France |
| Hôpital Roger Salengro | Lille | France |
| CHU de Marseille | Marseille | 13385 | France |
| CHU Montpellier | Montpellier | 34295 | France |
| CHU de Nancy | Nancy | 54035 | France |
| CHU de Nice | Nice | 06002 | France |
| Hôpital Tenon | Paris | 75970 | France |
| Hôpital de Poissy Saint Germain | Poissy | 78303 | France |
| CHU de Reims | Reims | 51092 | France |
| CHU de Strasbourg | Strasbourg | 67200 | France |
| 33352358 | Result | Maubeuge N, Deloire MSA, Brochet B, Ehrle N, Charre-Morin J, Saubusse A, Ruet A; BICAFMS study investigators. Validation of the French version of the minimal assessment of cognitive function in multiple sclerosis (MACFIMS). Mult Scler Relat Disord. 2021 Feb;48:102692. doi: 10.1016/j.msard.2020.102692. Epub 2020 Dec 17. |
| 34766866 | Result | Maubeuge N, Deloire MS, Brochet B, Charre-Morin J, Saubusse A, Ruet A. Validation of a Brief Computerized Cognitive Assessment in Multiple Sclerosis (BCCAMS) and comparison with reference batteries. Mult Scler. 2022 Jun;28(7):1112-1120. doi: 10.1177/13524585211054006. Epub 2021 Nov 12. |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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