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.
Study Type
OBSERVATIONAL
Enrollment
200
Department of Neurology, Charité - Universitätsmedizin Berlin
Berlin, Germany
RECRUITINGNeuroCure Clinical Research Center, Charité - Universitätsmedizin Berlin
Berlin, Germany
RECRUITINGtime (in days) until relapse during the observation period of four years
Time frame: 48 months
MRI - parameters: number and volume of T2 and gadolinium enhancing lesions, analysis of lesion patterns (spinal und cerebral MRI)
Time frame: 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
Time frame: 48 months
Optical Coherence Tomography (OCT): thickness of the retinal nerve fibre layer (RNFL) or total macular volume (TMV)
Time frame: 48 months
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