Cohort Study of Clinically Isolated Syndrome and Early Multiple Sclerosis

Study Overview
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Brief Summary
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A majority of patients with multiple sclerosis initially presents with a single demyelinating event, e.g. in the optic nerves, brain, brainstem or spinal cord, referred to as a clinically isolated syndrome (CIS). Not all patients with CIS get a relapse and develop multiple sclerosis but in those patients who do, irreversible damage of the central nervous system, e.g. axonal damage, is already detectable in that early stage of disease. Early initiation of immunomodulatory therapy is crucial for patients with clinically isolated syndrome who are at high risk for the development of multiple sclerosis. Vice versa identification of low risk patients could help to avoid an unnecessary therapy. In this prospective observational study we want to follow up patients with CIS and early multiple sclerosis over a period of four years and obtain clinical, laboratory and MRI - data in order to identify risk factors for relapses, prognostic factors and therapy response markers.

Official Title
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Clinically Isolated Syndrome and Newly Diagnosed Multiple Sclerosis: Diagnostic, Prognostic and Therapy - Response Markers - a Prospective Observational Study (Berlin CIS-COHORT)

Conditions
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Multiple Sclerosis, MS, Clinically Isolated Syndrome

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age > 18 years signed informed consent clinically isolated syndrome within the last 6 months diagnosis of multiple sclerosis within the last two years Exclusion Criteria: eye disease that could interfere with OCT (e.g. glaucoma, diabetic retinopathy) secondary progressive multiple sclerosis pregnancy contraindications for MRI, e.g. pacemaker, metal implants, allergy against gadolinium alcohol or drug abuse

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CIS or early relapsing-remitting MS<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time (in days) until relapse during the observation period of four years |  | 48 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI - parameters: number and volume of T2 and gadolinium enhancing lesions, analysis of lesion patterns (spinal und cerebral MRI) |  | 48 months | 
| biomarkers: RNA, microRNA, DNA, proteins, enzymes, autoantibodies, antiviral antibodies, virus DNA, Vitamin D and lipids in serum, plasma, peripheral cells, urine, saliva and CSF |  | 48 months | 
| Optical Coherence Tomography (OCT): thickness of the retinal nerve fibre layer (RNFL) or total macular volume (TMV) |  | 48 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OCT, Clinically isolated syndrome (CIS), Multiple sclerosis (MS), Immunomodulatory therapy, Prognostic markers, MRI