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A prospective longitudinal study of spinal cord lesions in multiple sclerosis: MRI monitoring and prognostic factors for active disease

A prospective longitudinal study of spinal cord lesions in multiple sclerosis: MRI monitoring and prognostic factors for active disease - MSpine

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON56629
Enrollment
155
Registered
2024-03-12
Start date
2024-08-06
Completion date
Unknown
Last updated
2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MS multiple sclerosis

Interventions

None listed

Sponsors

Zuyderland Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Patients diagnosed with relapsing-remitting MS (

Exclusion criteria

Exclusion criteria: Patients who are 65 years old 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, or patients who are pregnant at inclusion.

Design outcomes

Primary

MeasureTime frame
1. What is the incidence of asymptomatic spinal cord lesions in patients commencing DMT? 2. 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?

Secondary

MeasureTime frame
Secondary endpoints include which patient subgroups are prone to new spinal cord lesions at follow-up in early disease.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)