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| Name | Class |
|---|---|
| TEVA laboratories | UNKNOWN |
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Clinically isolated demyelinating syndromes (CIS) can evolve into multiple sclerosis (MS). Cognitive deficiencies could occur at this early stage and concern mainly information processing speed (IPS) and their mechanisms are not fully understood. Diffusion Tensor Imaging (DTI) can help in the understanding of these mechanisms.
This is a prospective cohort, observational, longitudinal, monocentric study. This study will include 60 patients with CIS followed for 1 year and 60 healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient | Experimental | Clinically isolated neurological syndrome (CIS) compatible with a demyelinating inflammatory episode within the central nervous system, potentially beginning multiple sclerosis (MS) whatever the mode of presentation |
|
| Control | Experimental | healthy subject |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brain MRI - Clinical and cognitive evaluation | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between fractional anisotropy (FA) value and cognitive z scores or cognitive impairment indexes for each domains | IPS, attention, working memory, episodic memory and executive functions), established by voxel-wise statistics (TBSS) in CIS patients | visit 2 - 1 year after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of skeleton of FA between CIS patients and healthy subjects | V2 - 1 year after the inclusion | |
| Comparison of cognitive scores at each test between CIS patients and controls | D0 and V2 - 1 year after the inclusion |
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Inclusion Criteria:
Patients:
Controls:
Exclusion Criteria:
Patients:
Controls:
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| Name | Affiliation | Role |
|---|---|---|
| Bruno BROCHET, Prof | University Hospital, Bordeaux | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Bordeaux | Bordeaux | 33000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27789541 | Derived | Moroso A, Ruet A, Lamargue-Hamel D, Munsch F, Deloire M, Coupe P, Ouallet JC, Planche V, Moscufo N, Meier DS, Tourdias T, Guttmann CR, Dousset V, Brochet B. Posterior lobules of the cerebellum and information processing speed at various stages of multiple sclerosis. J Neurol Neurosurg Psychiatry. 2017 Feb;88(2):146-151. doi: 10.1136/jnnp-2016-313867. Epub 2016 Oct 27. |
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|
| Eye movement | Other | Assessment of eye Movements (EyeBrain software) for only the group of 15 healthy subjects at baseline and at 12 months |
|
| Proportion of patients with cognitive impairment (≥ 3 tests impaired) and correlations with anxiety, depressive syndrome and fatigue | D0 and V2 - 1 year after the inclusion |
| Comparison of statistical maps of FA | mean cortical thickness and deep grey nuclei volumes with cognitive indexes in the 3 pre-define groups: cognitively preserved CIS patients at baseline and after one year; cognitively impaired CIS patients only after one year and cognitively impaired CIS patients at the two evaluations. | D0 and V2 - 1 year after the inclusion |
| Correlations between cognitive scores and mean cortical thickness and deep grey nuclei volumes in CIS patients | D0 and V2 - 1 year after the inclusion |
| Comparison of cognitive scores at each test and eye movements scores | D0 and V2 - 1 year after the inclusion |
| 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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| ID | Term |
|---|---|
| D005133 | Eye Movements |
| ID | Term |
|---|---|
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D009799 | Ocular Physiological Phenomena |
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