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Accelerated Brain Volume Loss in People With Multiple Sclerosis

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05408767
Acronym
BraVoLoinMS
Enrollment
70
Registered
2022-06-07
Start date
2021-01-01
Completion date
2022-05-01
Last updated
2022-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retrospective Study

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

National MS Center Melsbroek
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* MRI and volumetry performed minimum 48 and maximum 60 months apart

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frameDescription
The primary endpoint of this study will be the difference in annualized whole brain volume percentage change between the MS and control cohort4 - 5 yearsthe difference in annualized whole brain volume measured by Icometrix

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026