Actively Recruiting

Age: 18Years - 65Years
All Genders
NCT06827834

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

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

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

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here