The no evidence of disease activity (NEDA) concept in MS: impact of spinal cord MRI.
Elena Di Sabatino, Lorenzo Gaetani, Silvia Sperandei...
https://pubmed.ncbi.nlm.nih.gov/34820734Actively Recruiting
Led by Zuyderland Medisch Centrum · Updated on 2025-02-14
155
Participants Needed
5
Research Sites
N/A
Total Duration
Multiple sclerosis (MS) is a common disease affecting the central nervous system and a leading cause of neurological disability in young adults. Researchers are studying the occurrence of asymptomatic spinal cord lesions in recently diagnosed MS patients starting disease-modifying treatments (DMT). This observational study aims to understand how often these silent spinal cord lesions appear, especially when brain MRI shows no new disease activity, and to identify factors that may predict these lesions early in the disease course. Participants will undergo regular brain MRI scans as part of routine care, with additional spinal cord MRI scans collected over 27 months. Blood samples and clinical data will also be gathered, and cerebrospinal fluid markers will be analyzed if available. The study will explore associations between spinal cord lesions and various immune and clinical markers, including B-cell profiles, intrathecal antibody synthesis, and specific blood biomarkers. Patients will be recruited from multiple centers and followed closely to monitor disease activity. During the study, participants will have scheduled MRIs, outpatient visits, and blood collections to track neurological changes and disability progression. Outcome measurements include spinal cord lesion counts, brain MRI activity, disability scales, walking and hand function tests, and urinary symptoms. The research team will use these data to better understand disease activity and potentially improve monitoring strategies. The study will last 27 months, with an option to consider an extension phase based on findings.
CONDITIONS
Spinal Cord Monitoring in Multiple Sclerosis
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 27 months
Participants who undergo routine care are observed with additional spinal cord MRI scans, brain MRI, clinical assessments, and blood sample collections to monitor spinal cord lesions and disease activity.
Regular outpatient clinic visits and MRI scans during the 27 months
Total: 5 locations
1
Rijnstate
Arnhem, Gelderland, Netherlands, 6815AD
Not Yet Recruiting
2
Zuyderland Medisch Centrum
Geleen, Limburg, Netherlands, 6162BG
Actively Recruiting
3
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, North Brabant, Netherlands, 5223GZ
Not Yet Recruiting
4
Albert Schweitzer ziekenhuis
Dordrecht, South Holland, Netherlands, 3318AT
Actively Recruiting
5
Erasmus MC
Rotterdam, South Holland, Netherlands, 3015GD
Not Yet Recruiting
D
Demmie Bouweriks, MD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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