This study aims at investigating in vivo the macroscopic and microscopic aspects of brain and cervical cord neuroaxonal pathology in multiple sclerosis in a cohort of PPMS patients, by measuring brain and cervical cord atrophy, the ratio of N-…
ID
Source
Brief title
Condition
- Demyelinating disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To improve the sensitivity of surrogate markers for neuroaxonal damage for
clinical trials by combining MR measures longitudinally.
To assess if any baseline measures of atrophy, NAA/Cr, MTI or DTI predicts a
subgroup of patients who subsequently have greatest rates of atrophy.
Secondary outcome
To assess whether potential serum and urine biomarkers of neurodegeneration may
have added value.
To produce data for powering neuroprotective studies for all of the different
combinations of MR and biological fluid markers. This would allow selection of
measures in the future depending on the study requirements.
To assess reproducibility and reliability of the data between centers.
Background summary
Patients with primary progressive multiple sclerosis represent a subgroup with
clinical and MRI characteristics that differ from those of patients with
relapsing-remitting multiple sclerosis / secondary progressive multiple
sclerosis. They have less MRI lesion activity (lesion volume) and new lesions,
more lesional neuroaxonal damage and less inflammation, more diffuse damage and
spinal cord involvement. Thus, in PPMS patients the correlation between
conventional MRI measures and clinical disease severity is poor.
Study objective
This study aims at investigating in vivo the macroscopic and microscopic
aspects of brain and cervical cord neuroaxonal pathology in multiple sclerosis
in a cohort of PPMS patients, by measuring brain and cervical cord atrophy, the
ratio of N- Acetyl aspartate (NAA) and Creatine (Cr), magnetization transfer
variables and diffusion tensor metrics. Such measures will assess cortical and
subcortical structures * total brain, white and gray matter, thalamic, corpus
callosum and cervical cord volumes or area, thalamic and corpus callosum
NAA/Cr, whole brain, thalamic and corpus callosum MT measures, whole brain,
thalamic and corpus callosum diffusion tensor metrics.
This study will also collect clinical data in the form of EDSS and MSIS-29
scores. Furthermore, in order to relate MRI parameters of neuroaxonal
degeneration to body fluid markers of neuroaxonal degeneration, blood and urine
samples will be collected
Study design
Patients and healthy controls will be studied at baseline, 2 , 50 and 52 weeks.
MRI scanning will be performed. Disability will be assessed in patients using
Kurtzke*s Expanded Disability Status Scale (EDSS) (Kurtzke, 1983) and the
Multiple Sclerosis Impact Scale (MSIS -29) at the same time points. Blood and
urine samples will be collected from patients and healthy controls at the same
frequency as the imaging.
Study burden and risks
Subjects participating to this study will undergo four MRI scans. Also, on same
occasions urine and venous blood will be collected. Lastly, only patients
undergo each time a neurological exam and a selftest. This will all be done in
one year.
There are practically no risks associated with participation with this study.
The burden of the study will be primarily the boredom or inconvenience of lying
in a MRI scanner. Also, there is the burden of the needle (four times).
Finally, patients also have the burden of being subject four times to a
neurological exam and the selftest.
De Boelelaan 1117
1081 HV Amsterdam
NL
De Boelelaan 1117
1081 HV Amsterdam
NL
Listed location countries
Age
Inclusion criteria
MS patients: disease type should be primary progressive and EDSS should be 0-6.5
Both patients and healthy controls should have an age between 18-60 years of age
Exclusion criteria
Immunomodulatory medication
Claustrophobia or other contraindications to MRI
Neurological or psychiatric disease or history
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 | NL19229.029.07 |