We 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: 1…
ID
Source
Brief title
Condition
- Demyelinating disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
Secondary endpoints include which patient subgroups are prone to new spinal
cord lesions at follow-up in early disease.
Background 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. Over the past years, spinal cord MRI has improved significantly in
quality 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. Even though these spinal cord lesions may not exhibit symptoms, they
have a lasting impact on the accumulation of disability over the long term.
However, prospective data on the frequency and importance of asymptomatic
spinal cord lesions and therefore the potential role of spinal cord MRI in
treatment monitoring, is lacking.
Study objective
We 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:
1 What is the incidence of asymptomatic spinal cord lesions in patients
commencing DMT?
2 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, we will focus on factors such as urinary tract
symptoms, cerebrospinal fluid (CSF) profiles, lymfocyte composition in blood,
soluble blood markers, and clinical features.
Study design
This will be a prospective longitudinal, observational study.
Study burden and risks
All study appointments will ideally be planned together with regular follow up
visits, so patients will not have to visit the hospital additionally. Spinal
cord MRI will add extra 45 minutes scanning time, which could lead to some
(extra) discomfort, transient nausea, dizziness or a metallic taste. Blood
withdrawals require 3 extra vials (21ml) withdrawal in addition to regular
blood level controls. An extra venepuncture is only performed when necessary.
Clinical tests are performed in regular follow up, only now performed more
standardised and regularly. An additional questionnaire regarding urinary
symptoms will be performed, which will take less than 5 minuts.This involves
mainly prolonged appointment time. The risks and burdens are minimised as much
as possible by combining regular follow up and scanning with study proceedings.
Dr. H. van der Hoffplein 1
Sittard-Geleen 6162 BG
NL
Dr. H. van der Hoffplein 1
Sittard-Geleen 6162 BG
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL86278.096.24 |