assessment | detail | baseline | FU patients | FU HC | UV |
---|---|---|---|---|---|
schedule | Â | date of inclusion | annually year 1 to 15 | at year 1,2,4,8,15 | (x) optional (decision by study board) |
medical history & examination | |||||
 demographics |  | x | x | x | (x) |
 medical history | diagnosis, attack/relapse history, comorbidities, current symptoms and complaints, dietary and lifestyle factors | x | x | x | x |
 therapies | disease modifying therapy, relapse therapy, full drug list, supportive therapies | x | x | x | x |
 neurological examination | EDSS SARA | x x | x x | x | (x) (x) |
biospecimens | |||||
 blood samples | • biobanking 3 heparin (9ml each), 3 serum (10ml each), 3 EDTA (3,6 and 9 ml each), 1 PAX (2,5ml each). • clinical routine parameters • antibody testing | x | x | x | (x) |
 stool samples | standard 16 S rRNA sequencing, viability of bacteria, analysis of microbial metabolites | x | x | x | (x) |
 optional consent | use of biospecimens from clinical routine (cerebrospinal fluid, biopsy, plasma from plasmaphereses) |  |  |  | (x) |
nutrition and lifestyle | |||||
 body height and weight | BMI | x | x | x | (x) |
 body composition (BIA) | body fat mass, fat-free mass, total body water, body cell mass, extracellular mass | x | x | x | (x) |
 vital signs | blood pressure, heart rate | x | x | x | (x) |
 dietary habits and practice of stress-reducing behavior | FFQ and HOLISM life-style assessment | x | x | x | (x) |
 optional consent | continuous monitoring of interstitial glucose concentrations over 14 days | (x) | (x) | (x) | (x) |
patient reported outcomes | |||||
 questionnaires completed on site | NAS, GSLTPAQ, PDDS, MSWS-12, ABC-Scale, FSS, FSMC, PROMIS cognitive abilities, BPI, PainDETECT, BDI-II, HAQUAMS, PROMIS general health | x | x | x | (x) |
 web-based questionnaires (completed from home) | dietary intake (24-h-recall), FFQ | x | x | x | (x) |
quantitative assessment of motor functions | |||||
 hand grip force | hand-held dynamometer, 3x each side | x | x | x | (x) |
 timed tests | T25-FW, 9-HPT | x | x | x | (x) |
 visuo-perceptive motion analysis PASS-MS | short walks, static balance, stand-up-and-sit, stepping in place, finger tapping, finger-nose test | x | x | x | (x) |
cognitive assessment | |||||
 interview | handedness, education |  |  |  |  |
 Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) | SDMT, VLMT, BVMT-R | x | x | x | (x) |
vision and the visual system | |||||
 vision and the visual system | refraction, keratometry, non-contact tonometry, high- and low-contrast visual acuity, perimetry, VEP, OCT of macula and optic nerve head | x | x | x | (x) |
 optional consent | multi-focal VEP, electroretinogram (ERG) | (x) | (x) | (x) | (x) |
cerebrospinal magnetic-resonance imaging | |||||
 neuroaxis MRI | • cerebral: MPRAGE, T2-SPACE, FLAIR, MPM, DWI, rsfMRI • spinal: STIR (whole spine), PSIR (C2&C3 and C7/T1) | x | x | x | (x) |