Retrospective StudyBraVoLoinMSNCT05408767
Accelerated Brain Volume Loss in People With Multiple Sclerosis
An observational study of Retrospective Study, run by National MS Center Melsbroek at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Retrospective Study
- How many people
- 70 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2021to 1 May 2022
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Multiple Sclerosis
Who may be able to join
- MRI and volumetry performed minimum 48 and maximum 60 months apart
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Nationaal Multiple Sclerose Centrum Melsbroek
Melsbroek, Vlaams-Brabant, 1820
About this study
Official title: 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.
Read the 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.
- Conditions
- Retrospective Study
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 - 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start1 Jan 2021
- Primary completion1 Jan 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retrospective StudyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 70 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- National MS Center Melsbroek
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie D'hooghe, National MS Center Melsbroek
- Investigators
- Miguel D'haeseleer, Principal investigator, National MS center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05408767
- Sponsor's protocol ID
- BraVoLo in MS
- Acronym
- BraVoLoinMS
- Status last verified
- Jun 2022
- First submitted
- 2 Jun 2022
- Last updated
- 9 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated Brain Volume Loss in People With Multiple Sclerosis: do Real-world Observations Align With Standardized Research Findings?
- ClinicalTrials.gov ID
- NCT05408767
- Acronym / sponsor ID
- BraVoLoinMS / BraVoLo in MS
- Conditions
- Retrospective Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- National MS Center MelsbroekUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 7 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Multiple Sclerosis
Key inclusion criteria (1 listed)
- MRI and volumetry performed minimum 48 and maximum 60 months apart
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miguel D'haeseleer principal investigator
National MS center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retrospective Study, run by National MS Center Melsbroek at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2022.