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

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

— COGNIT-MS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05510817
• Other study ID #: B039202042775
• Status: Recruiting
• Phase: N/A
• Start date: June 6, 2022
• Est. completion date: June 6, 2026

Study information

• Verified date: December 2023
• Source: University Hospital of Mont-Godinne
• Contact: Frédéric London, MD
• Phone: +3282413345
• Email: frederic.london[@]chuuclnamur.uclouvain.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 6, 2026
• Est. primary completion date: June 6, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting

Intervention

Other:
• Multiparametric assessment
neuropsychological assessment, PRO measures, non-conventional MRI metrics

Locations

Country	Name	City	State
Belgium	CHU UCL Namur site Godinne	Yvoir	Namur

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital of Mont-Godinne	Saint-Luc University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predictors of disease evolution	EDSS score worsening from baseline	3 years
Primary	evaluation of evolutionary patterns of cognitive status (impaired vs non impaired)/changes from baseline	changes from baseline in cognitive scores	3 years
Primary	baseline predictors of future cognitive impairment	abnormal cognitive performances based on cognitive scores (using BCcogSEP battery)	3 years
Secondary	alteration in strategic white matter tracts at the early stages of RRMS, in patients with and without cognitive impairment	fractional anisotropy	3 years
Secondary	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