Multiparametric Assessment to Investigate Prognostic Factors for Disease Evolution a nd Evolutionary Patterns of Cognitive Status in RRMS (COGNIT-MS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Sclerosis, Relapsing-Remitting
• Intervention / Treatment: Other: Multiparametric assessment

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Frédéric London, MD; Phone Number: +3282413345; Email: frederic.london@chuuclnamur.uclouvain.be

Study Locations

• Belgium
  • Namur
    • Yvoir, Namur, Belgium
      • Recruiting
      • Chu Ucl Namur Site Godinne
      • Contact: Frédéric London, MD; Phone Number: +3281423345; Email: frederic.london@chuuclnamur.uclouvain.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: RRMS patients; RRMS patients initiating a new DMT	Other: Multiparametric assessment; neuropsychological assessment, PRO measures, non-conventional MRI metrics

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
alteration in strategic white matter tracts at the early stages of RRMS, in patients with and without cognitive impairment	fractional anisotropy	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	3 years

Collaborators and Investigators

• Sponsor: University Hospital of Mont-Godinne
• Collaborators: Saint-Luc University Hospital
• Investigators: Principal Investigator: Frédéric London, MD, University Hospital Mont-Godinne

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2022
• Primary Completion (Estimated): June 6, 2026
• Study Completion (Estimated): June 6, 2026

Study Registration Dates

• First Submitted: August 17, 2022
• First Submitted That Met QC Criteria: August 19, 2022
• First Posted (Actual): August 22, 2022

Study Record Updates

• Last Update Posted (Estimated): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 3, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: MRI; cognitive function; PROMs; evoked potentials
• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting
• Other Study ID Numbers: B039202042775

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No