Multiple sclerosis (MS), a chronic inflammatory disease of the central nervous system characterized by progressive loss of brain volume (brain atrophy).
Conditions
Interventions
Group 1: Retrospective analysis of MS patients (= 18 years, confirmed MS diagnosis according to the 2025 McDonald criteria) treated with cladribine. Using MRI scans performed annually as part of routi
Sponsors
Universitätsklinikum Essen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: MRI data from adult patients (=18 years) with a confirmed diagnosis of multiple sclerosis (MS) according to the 2025 McDonald criteria receiving treatment with cladribine.
Exclusion criteria
Exclusion criteria: MS patients who underwent only a single MRI examination. MS patients for whom no MPRAGE sequence (3D T1-weighted imaging) was acquired. MS patients whose MRI scans were deemed to be of insufficient image quality for analysis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| WHAT: Annual rate of global and regional brain atrophy (volume loss of gray and white matter as well as specific brain regions: thalamus, putamen, globus pallidus, amygdala, cerebellum, brainstem, hippocampus, nucleus accumbens) and change in T2 lesion volume, compared between patients treated with cladribine and patients treated with other disease-modifying therapies (ofatumumab, ocrelizumab, ozanimod). WHEN: Longitudinally, based on MRI scans performed annually as part of routine clinical care, before treatment initiation and throughout the follow-up period until study completion (31 December 2026). HOW: Volumetric analysis of MRI data (3D T1 MPRAGE sequences) using the standardized image processing software FSL (FMRIB Software Library) and FreeSurfer. | — |
Secondary
| Measure | Time frame |
|---|---|
| WHAT: (1) Atrophy patterns in relation to demographic characteristics (sex, age, marital status); (2) brain and lesion volume in relation to age at disease onset; (3) association between regional brain volume and degree of disability; (4) association between maintenance of NEDA-3 (No Evidence of Disease Activity: no relapse, no MRI activity, no EDSS progression) and regional atrophy rate; (5) difference in the effect of cladribine on brain atrophy rate in patients over 50 years compared to younger patients. WHEN: Longitudinally, based on annual MRI scans and clinical follow-up data until study completion (31 December 2026). HOW: Volumetric MRI analysis (FSL/FreeSurfer) combined with clinical follow-up data (EDSS - Expanded Disability Status Scale, relapse history, demographic and laboratory findings) from medical records of the MS outpatient clinic, statistically analyzed using correlation analyses (Pearson/Spearman) and Generalized Estimating Equations (GEE). | — |
Countries
Germany
Contacts
Public ContactRefik Pul
Universitätsklinikum Essen
Outcome results
None listed