Actively Recruiting

Age: 18Years - 65Years
All Genders
ID06827834

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

Led by Zuyderland Medisch Centrum · Updated on 2025-02-14

155

Participants Needed

5

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Multiple sclerosis (MS) is a common disease affecting the central nervous system and a leading cause of neurological disability in young adults. Researchers are studying the occurrence of asymptomatic spinal cord lesions in recently diagnosed MS patients starting disease-modifying treatments (DMT). This observational study aims to understand how often these silent spinal cord lesions appear, especially when brain MRI shows no new disease activity, and to identify factors that may predict these lesions early in the disease course. Participants will undergo regular brain MRI scans as part of routine care, with additional spinal cord MRI scans collected over 27 months. Blood samples and clinical data will also be gathered, and cerebrospinal fluid markers will be analyzed if available. The study will explore associations between spinal cord lesions and various immune and clinical markers, including B-cell profiles, intrathecal antibody synthesis, and specific blood biomarkers. Patients will be recruited from multiple centers and followed closely to monitor disease activity. During the study, participants will have scheduled MRIs, outpatient visits, and blood collections to track neurological changes and disability progression. Outcome measurements include spinal cord lesion counts, brain MRI activity, disability scales, walking and hand function tests, and urinary symptoms. The research team will use these data to better understand disease activity and potentially improve monitoring strategies. The study will last 27 months, with an option to consider an extension phase based on findings.

CONDITIONS

Brief 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 multiple sclerosis within 5 years of first clinical event
  • Treatment-na�ve patients starting approved disease-modifying treatment (DMT)
Not Eligible

You will not qualify if you...

  • First clinical event more than 5 years ago
  • Already started disease-modifying treatment
  • Unable to give informed consent
  • Unable to undergo local MRI due to physical problems, claustrophobia, or MRI contraindications such as implanted devices
  • Pregnant at time of inclusion

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - 27 months

Participants who undergo routine care are observed with additional spinal cord MRI scans, brain MRI, clinical assessments, and blood sample collections to monitor spinal cord lesions and disease activity.

Regular outpatient clinic visits and MRI scans during the 27 months

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

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Research Team

D

Demmie Bouweriks, MD

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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Frequently Asked Questions

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Published Research Related To This Trial

Effect of disease-modifying treatment on spinal cord lesion formation in multiple sclerosis: A retrospective observational study.

Daniel Kreiter, Romy Spee, Audrey Merry...

https://pubmed.ncbi.nlm.nih.gov/37683557

Association of asymptomatic spinal cord lesions and atrophy with disability 5 years after a clinically isolated syndrome.

W J Brownlee, D R Altmann, P Alves Da Mota...

https://pubmed.ncbi.nlm.nih.gov/27481210

Spinal cord lesions are frequently asymptomatic in relapsing-remitting multiple sclerosis: a retrospective MRI survey.

Franco Granella, Elena Tsantes, Stefania Graziuso...

https://pubmed.ncbi.nlm.nih.gov/31494713