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

Not Applicable

Recruiting

• Conditions: Multiple Sclerosis, Relapsing-Remitting
• Interventions: Other: Multiparametric assessment

• Registration Number: NCT05510817
• Lead Sponsor: University Hospital of Mont-Godinne

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.

Study Timeline

• Study Start: 2022-06-06
• Study First Submitted: 2022-08-17
• Study First Submitted QC: 2022-08-19
• Study First Posted: 2022-08-22
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-03
• Last Update Posted: 2023-12-05
• Primary Completion: 2026-06-06
• Study Completion: 2026-06-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RRMS patients	Multiparametric assessment	RRMS patients initiating a new DMT

Primary Outcome Measures

Name	Time	Method
evaluation of evolutionary patterns of cognitive status (impaired vs non impaired)/changes from baseline	3 years	changes from baseline in cognitive scores
baseline predictors of future cognitive impairment	3 years	abnormal cognitive performances based on cognitive scores (using BCcogSEP battery)
Predictors of disease evolution	3 years	EDSS score worsening from baseline

Secondary Outcome Measures

Name	Time	Method
predictive role of mEPS in predicting future disability	3 years	the Global Evoked Potential (GEP) score at study entry (baseline); EDSS score changes from baseline
alteration in strategic white matter tracts at the early stages of RRMS, in patients with and without cognitive impairment	3 years	fractional anisotropy

Trial Locations

Locations (1)

CHU UCL Namur site Godinne; 🇧🇪 Yvoir, Namur, Belgium