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| Name | Class |
|---|---|
| Saint-Luc University Hospital | UNKNOWN |
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This prospective study combining non conventional MRI techniques, neuropsychological screening tools, and a neurophysiological work-up using a sensitive and validated battery, will evaluate the predictive value of these measures and will explore the changes of the cognitive scores from baseline.
Neurologists are in need for reliable and robust predictive factors enabling to predict disease evolution and treatment response. Moreover, recent studies suggested that the evolution patterns of cognitive status in MS could be mixed, contradicting the concept that cognitive impairment in MS will inevitably increase over time.
The main aim of this prospective study is to investigate the predictors of disease evolution, as measured by the EDSS score, using a multiparametric assessment combining neuropsychological tests (BCcogSEP battery), MRI-derived metrics (volumetric brain parameters, tractography, diffusion tensor imaging and fiber tracking), patient-reported outcome measures, and neurophysiological tools (multimodal evoked potentials), and to explore the evolutionary patterns of cognitive status (changes from baseline).
The investigators planned to include 50 patients with active RRMS and initiating a new disease-modifying treatment.
Yearly assessment starting from study inclusion will be performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RRMS patients | Other | RRMS patients initiating a new DMT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multiparametric assessment | Other | neuropsychological assessment, PRO measures, non-conventional MRI metrics |
|
| Measure | Description | Time Frame |
|---|---|---|
| Predictors of disease evolution | EDSS score worsening from baseline | 3 years |
| evaluation of evolutionary patterns of cognitive status (impaired vs non impaired)/changes from baseline | changes from baseline in cognitive scores | 3 years |
| baseline predictors of future cognitive impairment | abnormal cognitive performances based on cognitive scores (using BCcogSEP battery) | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| alteration in strategic white matter tracts at the early stages of RRMS, in patients with and without cognitive impairment | fractional anisotropy | 3 years |
| predictive role of mEPS in predicting future disability |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Frédéric London, MD | Contact | +3282413345 | frederic.london@chuuclnamur.uclouvain.be |
| Name | Affiliation | Role |
|---|---|---|
| Frédéric London, MD | University Hospital Mont-Godinne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU UCL Namur site Godinne | Recruiting | Yvoir | Namur | Belgium |
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the Global Evoked Potential (GEP) score at study entry (baseline); EDSS score changes from baseline
| 3 years |
| 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 |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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