ongitudinal study of biological surrogate markers in primary progressive Multiple Sclersosis.
- Conditions
- MS10012303
- Registration Number
- NL-OMON31170
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 20
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
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To improve the sensitivity of surrogate markers for neuroaxonal damage for<br /><br>clinical trials by combining MR measures longitudinally.<br /><br>To assess if any baseline measures of atrophy, NAA/Cr, MTI or DTI predicts a<br /><br>subgroup of patients who subsequently have greatest rates of atrophy.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To assess whether potential serum and urine biomarkers of neurodegeneration may<br /><br>have added value.<br /><br>To produce data for powering neuroprotective studies for all of the different<br /><br>combinations of MR and biological fluid markers. This would allow selection of<br /><br>measures in the future depending on the study requirements.<br /><br>To assess reproducibility and reliability of the data between centers.</p><br>