ongitudinal prediction of progression in MS: The PrograMS Cohort

Recruiting

Conditions: Disseminated sclerosis
MS
10012303

Registration Number: NL-OMON51918

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 300

Inclusion Criteria

All people with MS and all healthy controls (HC) who have previously
participated in the Presto (2002/140), GeneOCT(2004/9), or LTD (2010/336)
studies (collectively also known as *PrograMS*) 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

A potential subject who meets any of the following criteria will be excluded
from participation in this study:

MS patients:
- Persons unable to undergo the minimal data collection (as described in
Methods section)

Controls:
- Comorbidity that interferes with participation in this study

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Cognitive measures<br /><br>• Neuropsychological test scores.<br /><br><br /><br>Neurological measures<br /><br>• Clinical scales.<br /><br><br /><br>Blood serum measures<br /><br>• (Changes in) blood biomarkers as defined in the MS biobank protocol.<br /><br><br /><br>Neuro-ophthalmological measures<br /><br>• (Changes in) retinal layer integrity and eye movements.<br /><br><br /><br>Questionnaires<br /><br>• (Changes in) mood and anxiety, fatigue, sleep disturbances, quality of life,<br /><br>coping style, personality, subjective motor function and cognitive complaints,<br /><br>work participation, stress, resilience.<br /><br><br /><br>Structural brain measures<br /><br>• (Changes in) white and grey matter tissue integrity and volume, as well as<br /><br>lesions.<br /><br><br /><br>Functional brain measures<br /><br>• (Changes in) functional activation as well as connectivity and network<br /><br>changes, measured with fMRI and MEG.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>We will identify (novel, clinical) measures and combinations of measures (e.g.<br /><br>grey matter atrophy patterns, serum NfL levels, dynamic network changes,<br /><br>structural network topology) to better understand the mechanism underlying<br /><br>progression, as well as (combinations of) measures that are most predictive for<br /><br>clinical progression.</p><br>