Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06410326
Status:
COMPLETED
Last Update Posted:
2024-05-13
First Post:
2024-04-04
Brief Title:
Mapping the Longitudinal Multidimensional Impact of MS in Relation to Variables Indicative of Neurological Reserve
Sponsor:
National MS Center Melsbroek
Organization:
National MS Center Melsbroek
Study Overview
Official Title:
Mapping the Longitudinal Multidimensional Impact of MS in Relation to Variables Indicative of Neurological Reserve
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Resilience
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None