MRI-Based Lesion Differentiation in Older Patients With Multiple Sclerosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-80
SponsorOslo University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 50-70 years
Clinically confirmed diagnosis of multiple sclerosis
Participation in the AgeMS study at Oslo University Hospital
Age 50-80 years
Disqualifiers
MRI contraindications
Severe psychiatric comorbidity
Major functional disability unrelated to MS or CSVD
MRI contraindications
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
1,000 Participants
are grouped into 2 trial groupsGroup A: Aging Multiple Sclerosis (MS)
Group B: Cerebral Small Vessel Disease (cSVD)
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline MRI (single MRI session for both cohorts)Secondary outcomes
1
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.
Time frame
From baseline through December 20302
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.
Time frame
Baseline; repeated assessments in the MS cohort through December 20303
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.
Time frame
Baseline; repeated assessments through December 20304
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.
Time frame
From baseline through December 2030Sponsors and contacts
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Source ClinicalTrials.gov