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Table 2 Overview of the assessments conducted at specified visits (optional parts are given in brackets)

From: Berlin Registry of Neuroimmunological entities (BERLimmun): protocol of a prospective observational study

assessment

detail

baseline

FU

patients

FU

HC

UV

schedule

 

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)

  1. FU Follow-up, UV Unscheduled visits, HC Healthy control individuals, EDSS Expanded disability status scale, SARA Scale for the assessment and rating of ataxia, BIA Bioelectrical impedance analysis, BICAMS Brief International Cognitive Assessment for Multiple Sclerosis, SDMT Symbol Digit Modality Test, VLMT Verbaler Lern- und Merkfähigkeitstest, BVMT-R Brief Visual Memory Test – Revised, PASS-MS Visuo-perceptive motion analysis, NAS Numeric rating scale measure of spasticity, GSLTPAQ Godin-Shephard Leisure-Time Physical Activity Questionnaire, PDDS Patient Determined Disease Steps, MSWS-12 12-item MS walking scale, ABC-Scale Activities-specific Balance Confidence Scale, FSS Fatigue Severity Scale, FSMC Fatigue Scale for Motor and Cognitive Functions, PROMIS cognitive function Patient-Reported Outcomes Measurement Information System – cognitive functions, BPI Brief Pain inventory, BDI-II Beck Depression Inventory-II, HAQUAMS Hamburg Quality of Life Questionnaire in Multiple Sclerosis, FFQ Food Frequency Questionnaire, VEP Visual evoked potentials, OCT Optical coherence tomography, 3D MPRAGE 3D Magnetization Prepared – RApid Gradient Echo, 3D SPACE 3D T2 sampling perfecting with application-optimized contrasts by using flip angle evolution, 3D FLAIR Fluid attenuated inversion recovery (FLAIR), 3D MPM 3D multi-parameter mapping, 3D DWI 3D diffusion weighted imaging, 3D rsfMRI 3D resting state functional MRI, 2D STIR Short tau inversion recovery, 2D PSIR 2D phase sensitive inversion recovery