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Clinical Trials in the Netherlands / NCT06827834
Recruiting Observational

Spinal Cord Monitoring in Multiple Sclerosis

NCT06827834 · tracked via the Priya Life Science Netherlands tracker
Sponsor
Zuyderland Medisch Centrum
Phase
Observational
Started
2024-08-06
Last updated
2025-02-14

Condition(s) studied

Multiple Sclerosis

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * Patients between 18 and 65 years old * Patients diagnosed with relapsing-remitting MS (≤5 years of first clinical event) * Treatment-naïve patients starting (currently in the Netherlands approved) DMT Exclusion Criteria: * Patients who presented first clinical event more than five years ago * Patients who have already started DMT * Patients who are incapable of giving informed consent * Patients who are unable to undergo local MRI scan, due to for instance * Physical problems, for instance due to size/obesity (not fitting in regular MRI scanner), not being able to lie flat for extended periods of time (e.g. due to pain, shortness of breath) * Due to claustrophobia * Patients who have contraindications for MRI scan, for instance * Due to MRI-unsafe or non-compatible implanted material/devices, such as pacemakers or ocular metal splinters * Patients who are pregnant at inclusion

Primary outcome measure(s)

  • Spinal cord lesion count — 27 months

Trial sites (5)

FacilityCityRegionStatus
Rijnstate Arnhem Gelderland Not Yet Recruiting
Zuyderland Medisch Centrum Geleen Limburg Recruiting
Jeroen Bosch Ziekenhuis 's-Hertogenbosch North Brabant Not Yet Recruiting
Albert Schweitzer ziekenhuis Dordrecht South Holland Recruiting
Erasmus MC Rotterdam South Holland Not Yet Recruiting

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Other trials for the same condition

Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis Active, not recruiting
Prepare the Mind: Can Coaching in Goal-directed Behaviour Increase the Success of Cognitive Rehabilitation in People With MS? Recruiting
Validation and Standardization of Paramagnetic Rim Lesion (PRL) Identification in Multiple Sclerosis Across MAGNIMS Centers Active, not recruiting
Randomized Autologous heMatopoietic Stem Cell Transplantation Versus Alemtuzumab, Cladribine or Ocrelizumab for RRMS (RAM-MS) Active, not recruiting
Non-inferiority Study of Rituximab Compared to Ocrelizumab in Relapsing MS Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06827834 on ClinicalTrials.gov ↗ ← All trials in the Netherlands