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

Conditions: MS
multiple sclerosis
10012303

Registration Number: NL-OMON56629

Lead Sponsor: Zuyderland Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 155

Inclusion Criteria

Patients diagnosed with relapsing-remitting MS (<5 years of first clinical
event)
Patient between 18-65 years old
Treatment-naïve patients starting (a currently in the Netherlands approved) DMT
(disease modifying treatment)

Exclusion Criteria

Patients who are <18 years old
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.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. What is the incidence of asymptomatic spinal cord lesions in patients<br /><br>commencing DMT?<br /><br>2. In the absence of radiological progression on brain imaging, how frequently<br /><br>do asymptomatic spinal cord lesions occur? In other words, how often is disease<br /><br>activity solely proven by spinal cord MRI and what is the<br /><br>number-needed-to-scan?</p><br>

Secondary Outcome Measures