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.
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 6, 2022
CompletedFirst Submitted
Initial submission to the registry
August 17, 2022
CompletedFirst Posted
Study publicly available on registry
August 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 6, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 6, 2026
December 5, 2023
December 1, 2023
4 years
August 17, 2022
December 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (2)
alteration in strategic white matter tracts at the early stages of RRMS, in patients with and without cognitive impairment
3 years
predictive role of mEPS in predicting future disability
3 years
Study Arms (1)
RRMS patients
OTHERRRMS patients initiating a new DMT
Interventions
neuropsychological assessment, PRO measures, non-conventional MRI metrics
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- progressive forms of MS
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital of Mont-Godinnelead
- Saint-Luc University Hospitalcollaborator
Study Sites (1)
CHU UCL Namur site Godinne
Yvoir, Namur, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frédéric London, MD
University Hospital Mont-Godinne
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 17, 2022
First Posted
August 22, 2022
Study Start
June 6, 2022
Primary Completion (Estimated)
June 6, 2026
Study Completion (Estimated)
June 6, 2026
Last Updated
December 5, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share