Multiparametric Assessment to Investigate Prognostic Factors for Disease Evolution a nd Evolutionary Patterns of Cognitive Status in RRMS (COGNIT-MS)
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|ClinicalTrials.gov Identifier: NCT05510817|
Recruitment Status : Recruiting
First Posted : August 22, 2022
Last Update Posted : August 22, 2022
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis, Relapsing-Remitting||Other: Multiparametric assessment||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multiparametric Clinical, Radiological, Neuropsychological, and Neurophysiological Assessment to Investigate Prognostic Factors for Disease Evolution and Treatment Response in MS: a Prospective Study.|
|Actual Study Start Date :||June 6, 2022|
|Estimated Primary Completion Date :||June 6, 2026|
|Estimated Study Completion Date :||June 6, 2026|
RRMS patients initiating a new DMT
Other: Multiparametric assessment
neuropsychological assessment, PRO measures, non-conventional MRI metrics
- Predictors of disease evolution [ Time Frame: 3 years ]EDSS score worsening from baseline
- evaluation of evolutionary patterns of cognitive status (impaired vs non impaired)/changes from baseline [ Time Frame: 3 years ]changes from baseline in cognitive scores
- baseline predictors of future cognitive impairment [ Time Frame: 3 years ]abnormal cognitive performances based on cognitive scores (using BCcogSEP battery)
- alteration in strategic white matter tracts at the early stages of RRMS, in patients with and without cognitive impairment [ Time Frame: 3 years ]fractional anisotropy
- predictive role of mEPS in predicting future disability [ Time Frame: 3 years ]the Global Evoked Potential (GEP) score at study entry (baseline); EDSS score changes from baseline
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05510817
|Contact: Frédéric London, MDfirstname.lastname@example.org|
|CHU UCL Namur site Godinne||Recruiting|
|Yvoir, Namur, Belgium|
|Contact: Frédéric London, MD +3281423345 email@example.com|
|Principal Investigator:||Frédéric London, MD||University Hospital Mont-Godinne|