Evaluation of Clinical, Morphologic and Biochemical Markers in Multiple Sclerosis

Study Overview
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Brief Summary
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By combining clinical, morphological and biochemical markers a better understanding of the formation and progression of multiple sclerosis (MS) should be obtained

Detailed Description
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The current study aims to comprehensively investigate the individual clinical, morphological and biochemical aspects of MS in order to elucidate underlying mechanisms leading to disease progression. This shall ultimately serve to identify imaging and biochemical markers, which may support clinical management of persons with MS (pwMS). The following markers will be assessed: demographics (age, sex), clinical (EDSS at baseline, disease duration); neuropsychological (SDMT (Symbol Digit Modalities Test) score); MRI (Magnetic Resonance Imaging) (lesion load, atrophy); Biochemical markers analyzed in cerebrospinal fluid (CSF), blood, DNA, RNA, peripheral blood mononuclear cells (PBMCs)

Official Title
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Evaluation of Clinical, Morphologic and Biochemical Markers in Multiple Sclerosis - MarkMS

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Other: blood sample


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with suspected or proven multiple sclerosis The participants are patients who are in inpatient or outpatient care of the Department of Neurology at the Medical University of Graz, Austria Exclusion Criteria: Excluded from the examinations are all patients for whom an MRI examination is impossible or problematic

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: blood sample|40-50 ml of blood is taken|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prediction of EDSS ( Expanded Disability Status Scale) progression by combined markers of the disease | EDSS score | a maximum of 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prediction of clinical relapses | Prediction of clinical relapses | a maximum of 4 years | 
| Conversion from CIS (Clinically Isolated Syndrome) to MS (Multiple Sclerosis) defined by MRI and clinical criteria | Conversion from CIS to MS defined by MRI and clinical criteria | a maximum of 4 years | 
| Time of transition to progressive form of MS | Time of transition to progressive form of MS | a maximum of 4 years | 
| Neuropsychological progression (decrease in SDMT performance) | Neuropsychological progression (decrease in SDMT performance) | a maximum of 4 years | 
| Increase in morphological damage (lesion load, atrophy) | Increase in morphological damage (lesion load, atrophy) | a maximum of 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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biomarker, progression, MRI, cognition