Multiparametric Assessment to Investigate Prognostic Factors for Disease Evolution a nd Evolutionary Patterns of Cognitive Status in RRMS

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Multiparametric Clinical, Radiological, Neuropsychological, and Neurophysiological Assessment to Investigate Prognostic Factors for Disease Evolution and Treatment Response in MS: a Prospective Study.

Conditions
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Multiple Sclerosis, Relapsing-Remitting

Intervention / Treatment
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* Other: Multiparametric assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: active MS, according to the Lublin criteria disease duration < 10 years before initiating or changing a disease-modifying therapies, relapse- and steroid-free for at least 1 month before MRI acquisition between 18-50 years old having given informed consent with no significant comorbidity other than MS or substance abuse that could interfere with cognitive performances Exclusion Criteria: progressive forms of MS

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: RRMS patients<br>RRMS patients initiating a new DMT | Other: Multiparametric assessment<br>* neuropsychological assessment, PRO measures, non-conventional MRI metrics<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | the Global Evoked Potential (GEP) score at study entry (baseline); EDSS score changes from baseline | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRI, evoked potentials, cognitive function, PROMs