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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CIS or early relapsing-remitting MS |
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| Measure | Description | Time Frame |
|---|---|---|
| time (in days) until relapse during the observation period of four years | 48 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients will be recruted at neurological outpatient clinics and neurologcial clinics of the charité and neurologists' medical practices.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Friedemann Paul, Prof. | Contact | 0049 30 450 | 539040 | friedemann.paul@charite.de |
| Klemens Ruprecht, Dr. | Contact | 0049 30 450 | 560374 | klemens.ruprecht@charite.de |
| Name | Affiliation | Role |
|---|---|---|
| Friedemann Paul, Prof. | Charite - Universitätsmedizin Berlin | Principal Investigator |
| Klemens Ruprecht, Dr. | Charite University, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology, Charité - Universitätsmedizin Berlin | Recruiting | Berlin | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38959589 | Derived | Gottwald NS, Asseyer S, Chien C, Brasanac J, Nauman AT, Rust R, Schmitz-Hubsch T, Strobl JB, Ruprecht K, Paul F, Regitz-Zagrosek V, Gold SM, Sperber PS. Impact of sex on clinical outcome in early Multiple Sclerosis. Mult Scler Relat Disord. 2024 Aug;88:105749. doi: 10.1016/j.msard.2024.105749. Epub 2024 Jun 29. |
| Label | URL |
|---|---|
| Homepage of the NeuroCure Clinical Research Center | View source |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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blood samples (serum and plasma, with DNA), urine, saliva, CSF (if routine lumbar puncture was performed, no additional lumbar punctures for the study)
| 48 months |
| Optical Coherence Tomography (OCT): thickness of the retinal nerve fibre layer (RNFL) or total macular volume (TMV) | 48 months |
| Judith Bellmann-Strobl, Dr. |
| Charite University, Berlin, Germany |
| Principal Investigator |
| NeuroCure Clinical Research Center, Charité - Universitätsmedizin Berlin | Recruiting | Berlin | Germany |
|
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |