RecruitingNCT06827834

Spinal Cord Monitoring in Multiple Sclerosis

A Prospective Longitudinal Study of Spinal Cord Lesions in Multiple Sclerosis: MRI Monitoring and Prognostic Factors for Active Disease


Sponsor

Zuyderland Medisch Centrum

Enrollment

155 participants

Start Date

Aug 6, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is monitoring the spinal cord of people who have recently been diagnosed with relapsing-remitting multiple sclerosis (MS) using MRI scans. The goal is to see how the spinal cord changes over time as patients start their first MS medication, and whether spinal cord MRI can serve as an early indicator of how well treatment is working. **You may be eligible if...** - You are between 18 and 65 years old - You have been recently diagnosed with relapsing-remitting MS (within 5 years of your first symptom) - You have not yet started any disease-modifying treatment (DMT) for MS and are about to begin one **You may NOT be eligible if...** - Your first MS episode was more than 5 years ago - You have already started MS medication - You are unable to give informed consent - You cannot have an MRI scan (e.g., due to body size, claustrophobia, or a metal implant) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(5)

Rijnstate

Arnhem, Gelderland, Netherlands

Zuyderland Medisch Centrum

Geleen, Limburg, Netherlands

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, North Brabant, Netherlands

Albert Schweitzer ziekenhuis

Dordrecht, South Holland, Netherlands

Erasmus MC

Rotterdam, South Holland, Netherlands

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NCT06827834


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