Multiple Sclerosis (MS)NCT07444047
MRI-Based Lesion Differentiation in Older Patients With Multiple Sclerosis
An observational study of Multiple Sclerosis (MS) and Cerebral Small Vessel Diseases, run by Oslo University Hospital at 1 site in Norway.
Trial summary
This study investigates whether an advanced MRI technique called Quantitative Susceptibility Mapping (QSM) can improve the differentiation of white matter lesions in people aged 50-70 years with multiple sclerosis (MS). Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Multiple Sclerosis (MS), Cerebral Small Vessel Diseases
- How many people
- 1,000 participants
- Where
- 1 siteNorway
- Study dates
- 11 May 2026to 31 Dec 2031
- Phase
- Observational
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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of two cohorts recruited at Oslo University Hospital. The multiple sclerosis (MS) cohort includes participants aged 50-70 years with a clinically confirmed MS diagnosis enrolled in the AgeMS study, an ongoing longitudinal study of older individuals with MS. Eligible participants are invited to participate by letter. Participants undergo semiannual MRI examinations and standardized neurological, cognitive, and patient-reported assessments through 2030. The cerebral small vessel disease (cSVD) control cohort includes patients aged 50-80 years with radiological evidence of hypertensive small vessel disease identified on MRI and recruited from the Stroke Unit. Eligible participants are approached during hospital admission and invited to participate. Eligible participants are approached during hospital admission and invited to participate. These participants undergo a single MRI session and standardized clinical testing.
Who may be able to join
- Age 50-70 years
- Clinically confirmed diagnosis of multiple sclerosis
- Participation in the AgeMS study at Oslo University Hospital
- Inclusion Criteria Cerebral Small Vessel Disease (cSVD) control cohort:
- Age 50-80 years
- Radiological evidence of hypertensive small vessel disease on MRI
- Good clinical recovery following transient ischemic attack (TIA), minor stroke, or stroke mimic diagnosis
Who cannot join
- MRI contraindications
- Severe psychiatric comorbidity
- Major functional disability unrelated to MS or CSVD
- Exclusion Criteria Cerebral Small Vessel Disease (cSVD) control cohort:
- MRI contraindications
- Probable or definite cerebral amyloid angiopathy according to Boston criteria 2.0
Show all 10Show fewer
- Genetic or inflammatory vasculopathies
- Persistent neurological deficits
- Severe psychiatric comorbidity
- Major functional disability unrelated to CSVD
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Oslo University Hospital
Oslo, Oslo, 0450
Anna Therese Bjerkreim, MD PhD, 004797000219, anthbj@ous-hf.no
Anna Therese Bjerkreim, MD PhD
About this study
Official title: Quantitative Susceptibility Mapping for Lesion Differentiation in Aging Multiple Sclerosis
This study investigates whether an advanced MRI technique called Quantitative Susceptibility Mapping (QSM) can improve the differentiation of white matter lesions in people aged 50-70 years with multiple sclerosis (MS). In older individuals with MS, white matter changes seen on MRI may be related to MS or to other types of white matter changes, most commonly age-related changes or chronic small vessel disease. These conditions can appear similar on conventional MRI scans, making interpretation challenging.
Participants will undergo routine clinical MRI, including a short additional QSM sequence, as well as brief cognitive and physical assessments. A comparison group with cerebral small vessel disease will also be included.
The goal of the study is to determine whether QSM can provide more precise lesion characterization and support more accurate clinical interpretation of MRI findings in older patients with MS.
Read the detailed description
Magnetic resonance imaging (MRI) is central to the diagnosis and monitoring of multiple sclerosis (MS). In individuals above 50 years of age, interpretation of white matter lesions becomes increasingly complex because lesions visible on conventional T2-weighted and FLAIR MRI may reflect MS-related demyelination, chronic cerebral small vessel disease (cSVD), or nonspecific age-related white matter changes. Conventional MRI has limited specificity in differentiating between these entities, which may complicate assessment of disease activity and progression.
Quantitative Susceptibility Mapping (QSM) is an advanced MRI technique that quantifies tissue magnetic susceptibility and provides complementary information to conventional imaging. Differences in susceptibility characteristics may reflect underlying tissue composition and microstructural properties, potentially allowing improved differentiation between demyelinating and vascular white matter lesions.
This prospective observational cohort study includes individuals aged 50-70 years with established MS undergoing routine clinical MRI follow-up, as well as an age-comparable cohort with clinical and radiological evidence of cSVD. Participants with MS will undergo longitudinal follow-up through routine clinical MRI and clinical assessments, whereas participants in the cSVD cohort will undergo a single study visit including MRI and standardized clinical testing. MRI examinations include standard clinical sequences with the addition of a short QSM acquisition. Clinical assessment includes brief standardized measures of cognitive processing speed, executive function, and physical function performed in conjunction with clinical visits.
Imaging analyses will focus on lesion-level and participant-level susceptibility characteristics and their distribution patterns across cohorts. Associations between QSM-derived measures and clinical function will be explored. The study is designed to evaluate the diagnostic utility and clinical relevance of QSM-based lesion characterization in older individuals with MS.
- Keywords
- Quantitative Susceptibility Mapping, QSM, White Matter Lesions, MRI, Lesion Differentiation, Aging, Neuroimaging, Demyelination, Small vessel Disease
- Medical subject headings
- Multiple Sclerosis, Cerebral Small Vessel Diseases, Demyelinating Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Aging Multiple Sclerosis (MS) | Individuals aged 50-70 years with established multiple sclerosis undergoing routine clinical MRI follow-up including an additional QSM sequence. | |
| Cerebral Small Vessel Disease (cSVD) | Age-comparable individuals with clinical and radiological evidence of cerebral small vessel disease undergoing MRI including an additional QSM sequence. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lesion-Level Quantitative Susceptibility (ppb) Within T2 FLAIR Hyperintense White Matter Lesions at Baseline
Quantitative susceptibility (ppb) will be measured using QSM within each segmented T2 FLAIR hyperintense white matter lesion. Lesion-level susceptibility values will be compared between lesions from the MS cohort and the cSVD cohort. Statistical analyses will account for clustering of multiple lesions within individual participants.
Measured: Baseline MRI (single MRI session for both cohorts)
Secondary outcomes (4)
Change From Baseline in Mean Lesion-Level Quantitative Susceptibility (ppb) Within T2 FLAIR Hyperintense White Matter Lesions in the MS Cohort
Quantitative susceptibility (ppb) will be measured within each segmented lesion at each time point. The outcome is change from baseline in lesion-level susceptibility over time. Analyses will account for clustering of multiple lesions within participants.
Measured: From baseline through December 2030
Association Between QSM-Derived Lesion Burden and Cognitive Composite z-Score
Cognitive function will be summarized at each visit as a composite z-score derived from standardized tests of processing speed and executive function. QSM-derived lesion characteristics will be summarized at the participant level (e.g., burden of QSM-positive vs QSM-negative lesions and lesion volume metrics). Associations between participant-level QSM-derived lesion burden and cognitive composite z-score will be analyzed using regression models.
Measured: Baseline; repeated assessments in the MS cohort through December 2030
Association Between QSM-Derived Lesion Burden and Physical Function Composite z-Score
Physical function will be summarized at each visit as a composite z-score derived from standardized mobility and balance assessments. QSM-derived lesion characteristics will be summarized at the participant level (e.g., burden of QSM-positive vs QSM-negative lesions and lesion volume metrics). Associations between participant-level QSM-derived lesion burden and physical function composite z-score will be analyzed using regression models.
Measured: Baseline; repeated assessments through December 2030
Association Between QSM-Derived Lesion Burden and Change From Baseline in Expanded Disability Status Scale (EDSS) Score
Disability progression will be assessed as change from baseline in Expanded Disability Status Scale (EDSS) score during follow-up. QSM-derived lesion characteristics will be summarized at the participant level (e.g., burden of QSM-positive vs QSM-negative lesions and lesion volume metrics). Associations between participant-level QSM-derived lesion burden and EDSS change over time will be analyzed using mixed-effects models.
Measured: From baseline through December 2030
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start11 May 2026
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis (MS)Studies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Bjerkreim, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07444047
- Sponsor's protocol ID
- 952017
- Other IDs
- OUS Project ID 25/27215
- Status last verified
- May 2026
- First submitted
- 19 Feb 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared. The study involves sensitive clinical and neuroimaging data collected under specific ethical approvals and data protection regulations. In accordance with institutional policies and regulatory requirements, individual-level data cannot be made publicly available.