MRI-Based Lesion Differentiation in Older Patients With Multiple Sclerosis

NCT07444047 | Not Yet Recruiting

• 2 other identifiers: 952017OUS Project ID 25/27215
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Multiple Sclerosis (MS); Cerebral Small Vessel Diseases

Keywords

Quantitative Susceptibility Mapping; QSM; White Matter Lesions; MRI; Lesion Differentiation; Aging; Neuroimaging; Demyelination; Small vessel Disease

Outcome Measures

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.

  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

  From baseline through December 2030

• Association Between QSM-Derived Lesion Burden and Cognitive Composite z-Score

  Baseline; repeated assessments in the MS cohort through December 2030

• Association Between QSM-Derived Lesion Burden and Physical Function Composite z-Score

  Baseline; repeated assessments through December 2030

• Association Between QSM-Derived Lesion Burden and Change From Baseline in Expanded Disability Status Scale (EDSS) Score

  From baseline through December 2030

Study Arms (2)

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.

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Age 50-70 years
• Clinically confirmed diagnosis of multiple sclerosis
• Participation in the AgeMS study at Oslo University Hospital
• 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

You may not qualify if:

• MRI contraindications
• Severe psychiatric comorbidity
• Major functional disability unrelated to MS or CSVD
• MRI contraindications
• Probable or definite cerebral amyloid angiopathy according to Boston criteria 2.0
• Genetic or inflammatory vasculopathies
• Persistent neurological deficits
• Severe psychiatric comorbidity
• Major functional disability unrelated to CSVD

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital

Oslo, Oslo County, 0450, Norway

Location

MeSH Terms

Conditions

Multiple Sclerosis; Cerebral Small Vessel Diseases; Demyelinating Diseases

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Anna Therese Bjerkreim, MD PhD

CONTACT

004797000219; anthbj@ous-hf.no

Lars Skattebøl, MD

CONTACT

004747299995; lars@skattebol.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Research Fellow

Study Record Dates

• First Submitted: February 19, 2026
• First Posted: March 2, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2031
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)