G35
Conditions
Interventions
Group 1: To participate in the study, patients must be at least 18 years old and either have been receiving stable DMD for at least 6 months, have not received DMD for at least 6 months or be consider
Sponsors
Experimental and Clinical Research Center (ECRC) - Charité
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: • Written declaration of consent for participation in the study on the use of sNfL in healthcare practice • Written declaration of consent for the ms register • Relapsing MS (RMS) -> active SPMS and RRMS • DMT stable for 6 month or no therapy for 6 months • Inclusion possible directly after diagnosis • No traumatic brain injury (TBI) or serious accident in the last 3 months
Exclusion criteria
Exclusion criteria: no relapsing-remitting course of ms
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Confirmation of the predictive value of sNfL for clinical and radiological disease activity (Expanded Disability Status Scale (EDSS), MRI activity (T2 lesions, brain volume), MSIS-29) • Investigation of the variability of sNfL over time and between different assays and different laboratories (validity of sNfL) | — |
Secondary
| Measure | Time frame |
|---|---|
| • Is sNfL, used alone or in combination with further disease activity indicators (relapse, MRI activity, EDSS), by treating neurologists to make treatment decisions (maintenance, restart, change of treatment)? • Are there relapse-independent GFAP changes over time as an indication for a relapse-independent progression? | — |
Countries
Germany
Contacts
Public ContactFriedemann Paul
Experimental and Clinical Research Center (ECRC) - Charité
Outcome results
None listed