No registrations found.
ID
Source
Brief title
Health condition
Multiple Sclerosis
Sponsors and support
Intervention
Outcome measures
Primary outcome
Our primary outcome is longitudinal cognitive decline, as measured by neuropsychological assessment (NPE).
Secondary outcome
Our secondary outcome is clinical progression, defined by worsening physical disability (EDSS). Parameters/predictors: Functional brain changes (functional MRI and magnetoencephalography, MEG); structural brain changes (MRI), ophthalmologic measurements (optical coherence tomography – OCT, and eye movements) and blood biomarkers.
Background summary
Single-center observational study, in which patients with MS and healthy controls who have previously participated in longitudinal studies at the MS Center Amsterdam are invited for a repeat visit, referred to as "Amsterdam MS cohort - round 2021". This will result in an unprecedented longitudinal MS cohort with advanced measurements (clinical, imaging and body fluid biomarkers) at three time points, roughly five years apart. The objective is to study underlying mechanisms of cognitive decline and clinical progression in MS and ultimately improve our understanding and prediction of clinical outcomes.
Study objective
By combining advanced modalities, a comprehensive model can be built for a better prediction of progression in MS.
Study design
Follow-up visit approximately 10-15 years after first observation (initiated at varying stages of the disease)
Inclusion criteria
All people with MS and all healthy controls who have previously participated in the Presto (local ethics committee number: 2002/140), GeneOCT (2004/9), or LTD (2010/336) studies (collectively also known as the “Amsterdam MS Cohort”) and have not provided objection to be contacted for follow-up study, or have been enquired to join the cohort based on the Amsterdam MS Cohort (2020/269) protocol.
Exclusion criteria
MS patients unable to undergo the minimal data collection (as described in Methods section) or comorbidity that interferes with participation in this study (controls).
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9409 |
| Other | METC VUmc : 2020.0601 |