G35
Conditions
Interventions
Group 1: In patients with relapsing multiple-measurement NfL, serum NfL is measured every 6 weeks. If serum NfL increases by at least 50% (with a Z score > 1.5) compared to the previous minimum value,
Sponsors
MUL-CT Cottbus, Klinik für Neurologie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: > Written consent is provided > Confirmed relapsing-remitting multiple sclerosis > Evidence of clinical or MRI activity (new T2 or Gd+ lesion) within the last 48 months > Routine brain MRI no older than 6 weeks at study enrollment with 3D T1 MPRage sequences and a 3D T2 FLAIR, both with a resolution of 1.0 x 1.0 mm² > No other active neurological disease other than headaches or migraine > No alcohol or drug addiction > No active cancer > No renal insufficiency with a GFR No highly active MS therapy category 3 (B-cell depletion, natalizumab, alemtuzumab)
Exclusion criteria
Exclusion criteria: >No written consent >Active neurological disease other than multiple sclerosis, migraine, or other headache disorders >A form of MS other than relapsing-remitting MS >Alcohol or drug addiction >Traumatic brain injury within the last 3 months prior to study entry >Active cancer >Known renal insufficiency (GFR Highly active MS – Category 3 therapy (B-cell depletion, natalizumab, alemtuzumab) >Contraindications for MRI examinations
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Positive predictive value of an increase of sNfL of > 50% with a sNfL Z score > 1.5 for new or enlarged T2 brain lesions as detected by automated MRI analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Sensitivity and specificity of an increase of sNfL to detect disease activity in cerebral MRI 2. Variance of sNfL concentrations and sNFL z scores 2. Kinetic of sNfL after an increase of sNfL of > 50% | — |
Countries
Germany
Contacts
Public ContactRobert Handreka
MUL-CT Cottbus, Klinik für Neurologie
Outcome results
None listed