Neurostatus Systems AG

Neurostatus
About

PLEASE NOTE: Since the beginning of August 2016 all Neurostatus products and services are operated and maintained by the Department of Neurology at the University Hospital Basel UHBS. Contact the UHBS also for a Licence to capture and validate electronic Neurostatus/EDSS examination data.

 

The Neurostatus/EDSS scale is the widely accepted primary endpoint of most clinical trials in Multiple Sclerosis. The products and services are developed in collaboration with the scientific experts of the MS team at the University Hospital Basel (Prof. L. Kappos) and cover the whole process from training and certification and Neurostatus/EDSS raters to electronic data capture, data management and scientific review within clinical trials.

HISTORICAL BACKGROUND

The (E)DSS was initially introduced in 1955 as the Disability Status Scale, a 10-step overall neurological disability rating scale. It was subsequently extended in 1983 by the introduction of half steps, leading to a total of 20 steps ranging from 0 to 10, separated by half-point increments (Expanded Disability Status Scale).

Since the 1982 Prof. L. Kappos was involved in the planning and conducting of numerous clinical MS trial and subsequently improved and standardized the EDSS scale (references), which became the Neurostatus, consisting of the Neurostatus Definitions and Scoring Sheet.

In parallel Neurostatus Systems and it's predecessor companies developed various training and certification programs in collaboration with the Prof. L. Kappos' MS team at the University Hospital Basel. All started with training videos in 1994, continued with a training CD/DVD Rom (1998/2005) and lead to the online certification platform Neurostatus e-Test in 2003.

In 2007 the development of the Neurostatus Algorithm, a digitized version of the complete Neurostatus Definitions, began and was finally validated and implemented in 2011. The complete Neurostatus e-Scoring system, including mobile electronic data capture and data management was introduced in 2013.

Neurostatus/EDSS has become a key endpoint of most phase III clinical trials in Multiple Sclerosis and is accepted by health authorities as a basis for label claims on disability.

STRUCTURE OF NEUROSTATUS/EDSS

The EDSS is based on a standardised neurological examination, but focuses on the symptoms that occur frequently in MS.

Assessment of the seven Functional Systems (FS: visual, brainstem, pyramidal, cerebellar, sensory, bowel & bladder and cerebral) is based on a standardised neurological examination.

Based on the FS scores and on the assessment of the ambulation, the EDSS step is determined. The range of the EDSS includes 20 half steps from 0 to 10, with EDSS step 0 corresponding to a completely normal examination and EDSS step 10 to death due to MS. For EDSS ratings between 0 and 4, the scale relies mainly on the scores of the individual FS. For ratings over 4, the EDSS is primarily determined by the ability and range of walking.

WORLDWIDE DISTRIBUTION

Neurostatus products are used worldwide:

  • Approx. 70 ongoing MS and NMO studies use Neurostatus e-Test
  • 2 studies use Neurostatus e-Scoring since 2013
  • 3 Studies e-Scoring Algorithm since 2011
  • More than 130 studies use Neurostatus e-Test Qualification since 2003
  • More than 10’000 Neurologists have active accounts on Neurostatus.net
  • More than 25’000 active e-Test Qualifications
  • Approx. 80 new registrations monthly on Neurostatus.net
  • Approx. 10'000 Training DVD ROMs delivered