In our longitudinal study we would like to investigate whether measures of neuronal damage, glial damage and oxidative stress are correlated with the speed of progression of disability. We would also like to investigate whether these variables…
ID
Source
Brief title
Condition
- Demyelinating disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- The correlation of the measured biomarkers and skin autofluorescence with the
porgression of disability (as measured with the EDSS and MSSS scales) over a
period of five and ten years
Secondary outcome
- The correlation of the measured variables with fatigue (measured with the FSS
scale)
- The difference in the measured variables between MS-patients and healthy
control persons
Background summary
The disease course of multiple sclerosis (MS), an inflammatory and degenerative
disease of the central nervous system, is very variable. While some patients
experience quickly worsening disability, others have no or only few symptoms
even after a very long disease duration. It is uncertain which
pathophysiological mechanisms underlie inflammation and neurodegeneration in
MS, and it is also impossible to predict future disease course at the beginning
of the disease.
Previous research has been undertaken to identify markers in blood or
cerebrospinal fluid of MS patients, which are correlated to disease activity.
In order to do this, the concentration of a marker substance was compared
between healthy control persons and patients with MS in small cross-sectional
studies. The goal of these studies was the identification of markers of acute
inflammatory cell and tissue damage.
It has recently become evident that a slowly progressing neurodegeneration is
another mechanism that contributes to increasing disability in MS. A biomarker
which could predict the most patient-relevant outcome, i.e. the speed of
progression, would be the best marker of disease activity.
It has been suggested in earlier studies, that oxidative stress may play a role
in the pathophysiology of MS. Measures of oxidative stress have not been
compared to measures of the speed of progression of disability.
In this explorative longitudinal study we would like to investigate whether
markers of glial or neuronal damage, of inflammation and of oxidative stress in
the blood plasma of patients with MS are correlated with measures of the speed
of progression in MS.
Study objective
In our longitudinal study we would like to investigate whether measures of
neuronal damage, glial damage and oxidative stress are correlated with the
speed of progression of disability. We would also like to investigate whether
these variables differ between patients with MS and healthy control persons.
Study design
Explorative longitudinal study (duration of study: ten years) with yearly
measurements.
Study burden and risks
Each year:
- neurologic examination (to document the extent of disability)
- non-invasive measurement of skin-autofluorescence
- taking of a blood sample
Hanseplein 1
9713GZ
Nederland
Hanseplein 1
9713GZ
Nederland
Listed location countries
Age
Inclusion criteria
- age of eightteen years or older
- written informed consent
- MS-patients: a diagnosis of multiple sclerosis, according to the McDonald-criteria.
Exclusion criteria
- contraindication for taking a blood sample
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 | NL14328.042.06 |