Monitoring spinal cord health in patients with multiple sclerosis
A Prospective Longitudinal Study of Spinal Cord Lesions in Multiple Sclerosis: MRI Monitoring and Prognostic Factors for Active Disease
This study is trying to see if spinal cord scans can help find hidden problems in people with newly diagnosed multiple sclerosis who are starting treatment, even if their brain scans look normal.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 155 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Zuyderland Medisch Centrum Academic / other |
| Locations | 5 sites (Arnhem, Gelderland and 4 other locations) |
| Trial ID | NCT06827834 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect spinal cord MRI data from recently diagnosed patients with relapsing-remitting multiple sclerosis who are starting disease-modifying therapy. The research will investigate the incidence of asymptomatic spinal cord lesions and their impact on disease progression, particularly in patients who do not show brain MRI activity. By identifying these lesions, the study seeks to enhance understanding of disease activity and improve monitoring strategies for MS patients.
Who should consider this trial
Good fit: Ideal candidates are treatment-naïve adults aged 18 to 65 diagnosed with relapsing-remitting multiple sclerosis within five years of their first clinical event.
Not a fit: Patients who have been diagnosed with MS for more than five years or those who have already started disease-modifying therapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better monitoring and treatment strategies for multiple sclerosis, potentially improving long-term patient outcomes.
How similar studies have performed: While there is existing evidence regarding asymptomatic spinal cord lesions, this study's specific approach to prospectively monitor these lesions in a clinical setting is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Arnhem, Gelderland and 4 other locations
- Rijnstate — Arnhem, Gelderland, Netherlands (Not_yet_recruiting)
- Zuyderland Medisch Centrum — Geleen, Limburg, Netherlands (Recruiting)
- Jeroen Bosch Ziekenhuis — 's-Hertogenbosch, North Brabant, Netherlands (Not_yet_recruiting)
- Albert Schweitzer ziekenhuis — Dordrecht, South Holland, Netherlands (Recruiting)
- Erasmus MC — Rotterdam, South Holland, Netherlands (Not_yet_recruiting)
Study contacts
- Study coordinator: Demmie Bouweriks, MD
- Email: d.bouweriks@zuyderland.nl
- Phone: +31884597603
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.