Clinical trial NCT06410326: Mapping the Longitudinal, Multidimensional Impact of MS in Relation to Variables Indicative of Neurological Reserve
Official title: Mapping the Longitudinal, Multidimensional Impact of MS in Relation to Variables Indicative of Neurological Reserve
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lead sponsor: National MS Center Melsbroek
Sponsor class: OTHER
Collaborators: name: Vrije Universiteit Brussel
First posted: 2024-05-13
Enrollment: 2600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Multiple Sclerosis patients followed in the National MS center Belgium

Brief summary: Some MS patients quickly accumulate neurological deficits, while others remain well for decades. Even though associations with age, sex, health behaviors, comorbidities and social determinants of health are widely acknowledged, the clinical heterogeneity in MS is poorly understood and variables with a robust prognostic value are lacking. Recent data suggest a key role for resilience in the central nervous system, potentially supporting the concept of neurological reserve in MS.

Detailed description: The first phase of the study will take place at the National MS Center Melsbroek (NMSC). All data from the EDMUS database, a single center database at the NMSC, will be exported and checked (quantity, quality) aiming to come to a well-organized MS data structure. This MS register will be completed with volume data (intracranial, spinal canal) in a subset of patients. As a substantial number of MS patients are followed over the long-term in the MS center, the investigators expect to have longitudinal data well beyond a disease duration of 10 years at least for part of the patients. Following the export and cleaning phase of the data, the investigators will come to the basic descriptive statistics. This allows us to have an overview of all data and determine the most appropriate baseline variables or covariates as well as to define the most appropriate outcome variables. Multivariable regression analysis will be used to predict the value of outcome variables based on the independent variables whose values are known. In view of the relevance of age and disease duration in the context of MS disability and progression, time-to-event analysis will be performed, with the time to reach irreversible milestones of ambulatory disability as outcome.

In case of associations, the second phase of the study will be initiated for further analysis at the AIMS research group, VUB. At the AIMS group, VUB, the potential of false positive findings will be addressed using more sophisticated approaches (splitting cohorts in exploratory and discovery cohort, or cross-fold validation).

Eligibility criteria: Inclusion Criteria:

diagnosis of MS needs to be based on diagnostic criteria valid at the time of data entry and confirmed during follow up

Exclusion Criteria:

* Neuromyelitis Optica diagnosis, AQ4 positive or MOG positive

Primary outcomes:
measure: EDSS
timeFrame: 2 years
measure: Functional tests
timeFrame: 2 years
measure: Cognitive tests
timeFrame: 2 years
measure: The EQ-Visual Analog Score (EQ-VAS)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Melsbroek
country: Belgium
facility: Nationaal Multiple Sclerose Centrum Melsbroek
state: Vlaams-Brabant
Study officials:
References: