Accelerated Brain Volume Loss in People With Multiple Sclerosis (BraVoLoinMS)

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

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.

Study Overview

• Status: Completed
• Conditions: Retrospective Study

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.

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• Belgium
  • Vlaams-Brabant
    • Melsbroek, Vlaams-Brabant, Belgium, 1820
      • Nationaal Multiple Sclerose Centrum Melsbroek

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Multiple Sclerosis

Description

Inclusion Criteria:

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

Exclusion Criteria:

• none

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary endpoint of this study will be the difference in annualized whole brain volume percentage change between the MS and control cohort	the difference in annualized whole brain volume measured by Icometrix	4 - 5 years

Collaborators and Investigators

• Sponsor: National MS Center Melsbroek
• Investigators: Principal Investigator: Miguel D'haeseleer, National MS center

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): January 1, 2022
• Study Completion (Actual): May 1, 2022

Study Registration Dates

• First Submitted: June 2, 2022
• First Submitted That Met QC Criteria: June 2, 2022
• First Posted (Actual): June 7, 2022

Study Record Updates

• Last Update Posted (Actual): June 9, 2022
• Last Update Submitted That Met QC Criteria: June 7, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis
• Other Study ID Numbers: BraVoLo in MS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No