Accelerated Brain Volume Loss in People With Multiple Sclerosis

To explore whether brain volume loss (BVL) in people with multiple sclerosis (MS), assessed on magnetic imaging (MRI) data obtained during routine medical follow-up (and thus outside a standardized research environment), differs from that of healthy controls and correlates with measures of physical and/or cognitive disability, the latter also gathered during regular clinical practice.

Completed

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Key information

Conditions

Retrospective Study

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nationaal Multiple Sclerose Centrum Melsbroek

Melsbroek, Vlaams-Brabant, 1820, Belgium

About this study

This project will not be the first study on real-world data in an existing MS cohort. A NMSC research group has already reported on the contribution of a single brain volumetric assessment to the prediction of MS-related disability10 - with distinct patterns for the Expanded Disability Status Scale (EDSS) as a measure of physical disability11, and Symbol Digit Modalities Test (SDMT) as a measure of cognitive disability12 - and found a threshold effect for the lowest brain volumes with regard to SDMT worsening over time10. Ghione and co-workers, in turn, have demonstrated a positive correlation between annualized BVL and EDSS progression based on the EDSS in a very large sample containing nearly 2,000 individuals13. The novelty of this new study lies in the fact that the investigators want to explore the correlations between BVL and changes in an expanded set of routinely collected clinical variables in our center - in addition to the EDSS score - such as Timed 25-Feet Walk Test (T25FWT)14, 9-Hole Peg Test (9HPT)15 and SDMT.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

MRI and volumetry performed minimum 48 and maximum 60 months apart

Exclusion criteria

none

Treatment and study plan

Primary outcomes

The primary endpoint of this study will be the difference in annualized whole brain volume percentage change between the MS and control cohort

Time frame: 4 - 5 years

the difference in annualized whole brain volume measured by Icometrix

Sponsors and collaborators

Lead sponsor

National MS Center Melsbroek

Other

Registry information

Official study title

Accelerated Brain Volume Loss in People With Multiple Sclerosis: do Real-world Observations Align With Standardized Research Findings?

Acronym: BraVoLoinMS

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Jun 7, 2022
Registry last updated: Jun 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed