Actively Recruiting
Spinal Cord Monitoring in Multiple Sclerosis
Led by Zuyderland Medisch Centrum · Updated on 2025-02-14
155
Participants Needed
5
Research Sites
199 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Multiple sclerosis (MS) is the most common demyelinating disease of the central nervous system and the most common cause of non-traumatic neurological disability in young adults. Magnetic resonance imaging (MRI) is the most important paraclinical investigation used in the diagnosis and monitoring of the disease. In the past years, spinal cord MRI has improved significantly and has become an important part of the diagnostic workup for MS. Presently, follow-up imaging of the spinal cord is only performed when spinal cord related symptoms occur. However, there is increasing evidence that asymptomatic spinal cord lesions can occur, independently of brain disease activity. Despite these cord lesions being asymptomatic, they impact disability accrual in the long term. Although this might be an imaging marker for monitoring and treatment, it is not yet applied in the clinical setting. The investigators will prospectively collect spinal cord MRI data (in addition to routine brain MRI), and blood-based biomarkers (plus cerebral spinal fluid markers, if available), in recently diagnosed MS patients, to address the following research questions: * What is the incidence of asymptomatic spinal cord lesions in patients commencing DMT? * And in the absence of radiological progression on brain imaging, how frequently do asymptomatic spinal cord lesions occur? In other words, how often is disease activity solely proven by spinal cord MRI and what is the number-needed-to-scan? * A secondary objective is to investigate which patients are predisposed to developing new spinal cord lesions during follow-up in the early stages of the disease. For this question, factors such as cerebrospinal fluid (CSF) profiles, B-cell composition in blood, soluble blood markers, and clinical features will be focused on.
CONDITIONS
Official Title
Spinal Cord Monitoring in Multiple Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients between 18 and 65 years old
- Diagnosed with relapsing-remitting MS with first clinical event within 5 years
- Treatment-nafve patients starting approved disease-modifying therapy
You will not qualify if you...
- First clinical event occurred more than 5 years ago
- Already started disease-modifying therapy
- Unable to give informed consent
- Unable to undergo MRI due to physical issues or claustrophobia
- Contraindications for MRI such as implanted devices or metal splinters
- Pregnant at the time of inclusion
AI-Screening
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Trial Site Locations
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
Research Team
D
Demmie Bouweriks, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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