RC2NB aims to be a pioneer in exploring the digital future using digital devices and wearables for patient assessment and care. In an increasingly digitally connected world, we aim to integrate research into care with the goal of providing real-world evidence of high quality and validity.

The mission of Workstream 1 is to advance digital assessment methods for MS care and research. With “dreaMS”, we aim to establish and validate smartphone and wearable-based digital measures for MS. The group received a starting grant by Innosuisse – Schweizerische Agentur für Innovationsförderung – and additional funding by grants from Roche, Novartis and others to the Foundation for Clinical Neuroimmunology and Neuroscience Basel.

In 2024 we completed recruitment of our Swiss-wide validation study 1 (VS1, NCT05009160). The recruitment of a total of 275 participants with MS and 50 healthy volunteers was made possible through support by the Swiss MS Cohort Study (SMSC) centers at the University Hospital Zurich, the University Hospital Lausanne (CHUV), the EOC Lugano and the Cantonal Hospitals St. Gallen and Aarau. The participants are followed up for at least 2 years. 30 participants who completed the 2-year core study have already entered a 2-year extension study. By including only participants from the SMSC, we have ideal conditions to compare the validity and sensitivity for change over time of the new digital metrics derived from dreaMS with the high-quality and well-standardized clinical, laboratory and imaging markers of disease severity and progression obtained in the SMSC.

To investigate the relative difficulty between levels, reliability, practice effects, and ability to measure change in performance over time, we conducted the CoGames study with 76 healthy volunteers (Pless S. et al., J Neurol, in press).

All difficulty levels of all games reached our predefined cut-offs for test-retest reliability, and we obtained data allowing to quantify the difficulty differences between levels and practice effects. Overall, the results of CoGames support our assumption that these adaptive, digital, and gamified cognitive tests can be used as reliable and well- accepted assessment- and monitoring tools in MS but also in other diseases affecting cognitive functions.

The second key element in our scientific validation strategy is the international Validation Study 2. This multinational cohort study will include about 600 participants across Europe and North America and aims to replicate the results of Validation Study 1 with a stronger focus on patient-centered outcomes and optimal generalizability of findings.

The start of this investigator initiated study (planned for end of 2024 is now delayed to Q3 2025 due to unforeseen administrative delays and our decision to replace modules of FLOODLIGHT (Roche) that are complementing dreaMS modules in VS1. As FLOODLIGHT tests won't be available anymore for VS2, we decided to replace them by integrating new equivalent tests.

Neurostatus-UHB AG operates as a 100% subsidiary of the University Hospital and, as of December 2024, has a team of 25 employees. In 2024, the Neurostatus-EDSS was licensed to 94 active phase II/III MS trials, of which one third is using the digital version that has been shown to significantly improve consistency of assessments. (Neurostatus-eEDSS). This digital version is also used in the dreaMS validation studies 1 and 2. For industry sponsored clinical trials Neurostatus-eEDSS is implemented in collaboration with established electronic clinical outcome assessment (eCOA) companies that are granted non- exclusive licenses.
In addition to the guidance and substantial support during implementation in the environments of these eCROs, the team of Neurostatus-UHB Ltd is responsible for the continuous quality control and provided more than 10’500 individual expert-reviews for RCTs in 2024.

The SMARTCARE study was completed and showed that trained healthcare professionals are able to assess the Neurostatus-EDSS with equal accuracy as Neurologists. (Mallucci G et al., MSJ 2024). This is an important step towards better quality in decentralized clinical studies.

Even a seasoned scale as the EDSS, first described in 1955 and 1983, may be subject to further improvement: In the eCluster project we apply AI methods to large sets of Neurostatus eEDSS data aiming to achieve more granular (sub)gradings in the EDSS score range of 4.5 to 6.5 that -in the current version- is dominated by ambulation and does not take into account changes in other functional domains (M. Greselin, MSJ, in press).