Clinical trial NCT05510817: Multiparametric Assessment to Investigate Prognostic Factors for Disease Evolution a nd Evolutionary Patterns of Cognitive Status in RRMS
Official title: Multiparametric Clinical, Radiological, Neuropsychological, and Neurophysiological Assessment to Investigate Prognostic Factors for Disease Evolution and Treatment Response in MS: a Prospective Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: MRI
evoked potentials
cognitive function
PROMs
Lead sponsor: University Hospital of Mont-Godinne
Sponsor class: OTHER
Collaborators: name: Saint-Luc University Hospital
First posted: 2022-08-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Predictors of disease evolution
timeFrame: 3 years
measure: evaluation of evolutionary patterns of cognitive status (impaired vs non impaired)/changes from baseline
timeFrame: 3 years
measure: baseline predictors of future cognitive impairment
timeFrame: 3 years
Secondary outcomes:
measure: alteration in strategic white matter tracts at the early stages of RRMS, in patients with and without cognitive impairment
timeFrame: 3 years
measure: predictive role of mEPS in predicting future disability
timeFrame: 3 years
Other outcomes:
Locations:
city: Yvoir
country: Belgium
facility: CHU UCL Namur site Godinne
state: Namur
Study officials:
affiliation: University Hospital Mont-Godinne
name: Frédéric London, MD
role: PRINCIPAL_INVESTIGATOR
References: