An interventional study of Multiparametric assessment in Multiple Sclerosis, Relapsing-Remitting, sponsored by University Hospital of Mont-Godinne. Recruiting at 1 site in Belgium. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2023-12-05.
Sponsored by University Hospital of Mont-Godinne · Not applicable, Interventional, and Other
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.
618 studies on the registry are indexed under Multiple Sclerosis, Relapsing-Remitting; 82 are open to participants now.
This study's planned enrollment of 50 is below the median of 66 across 437 interventional studies indexed under Multiple Sclerosis, Relapsing-Remitting.
Browse Multiple Sclerosis, Relapsing-Remitting studies →University Hospital of Mont-Godinne is the lead sponsor of 24 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RRMS patients initiating a new DMT
Other: Multiparametric assessment
neuropsychological assessment, PRO measures, non-conventional MRI metrics
Predictors of disease evolution
EDSS score worsening from baseline
Time frame: 3 years
evaluation of evolutionary patterns of cognitive status (impaired vs non impaired)/changes from baseline
changes from baseline in cognitive scores
Time frame: 3 years
baseline predictors of future cognitive impairment
abnormal cognitive performances based on cognitive scores (using BCcogSEP battery)
Time frame: 3 years
alteration in strategic white matter tracts at the early stages of RRMS, in patients with and without cognitive impairment
fractional anisotropy
Time frame: 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
Time frame: 3 years
Plan to share: No
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Multiple Sclerosis, Relapsing-Remitting →
University Hospital of Mont-Godinne