The main players in this still young research area are Dr. Yvonne Naegelin, Dr. Johannes Lorscheider and Dr. Marcus D'Souza.
The goal of the project "dreams" is to use smartphones and so-called "wearables" to better characterize the course of MS. The built-in sensors in today's smartphones allow differentiated analyses of movement patterns. At the same time, smartphones are usually used on a daily basis and can therefore provide a more realistic picture of the activities of their owners than visits to the doctor's office, which are only semi-annual or annual. However, generating digital biomarkers from the wide variety of available data, i.e. parameters that allow meaningful statements about the course and prognosis of the disease, is very demanding.Dreams uses a smartphone app for this purpose that not only analyzes movement but also cognition, visual function, mood and quality of life. The app was developed in cooperation with Basel-based Healios AG, which specializes in software solutions in the field of "digital health". This cooperation is supported by the Swiss Agency for Innovation Promotion (Innosuisse). A feasibility study is currently underway in which the app and the newly developed digital biomarkers are being tested for technical reliability and user-friendliness on MS patients and healthy volunteers.
Next year, longitudinal studies in the Swiss MS cohort and the international SUMMIT cohort will follow to investigate the value of digital biomarkers for the assessment of progression, also in comparison with established test methods. For these and future studies the secure transfer, processing and storage of the generated data is essential. Together with Bram Stieltjes, MD, PhD, Head of the Department Research and Analytic Services (FAS) of Computer Science at the University Hospital Basel, the data flow into a newly built "Data Warehouse" was therefore established. From here, anonymized data can be made available to other internal and external collaboration partners, such as the university sciCORE for more complex analyses.
A further project in Workstream 1 concerns the standardization and digitalization of clinical neurological examinations. In the 1990s, under the direction of Ludwig Kappos, the Neurostatus-Expanded Disability Status Scale (Neurostatus-EDSS) was developed for recording clinical symptoms in MS patients. Since then, Neurostatus-EDSS has been used as a primary or secondary clinical endpoint in more than 200 clinical phase 2 and phase 3 studies, including all pivotal studies for MS drugs. In recent years, a digital version developed by the Neurostatus-UHB working group has been increasingly used. This Neurostatus eEDSS® can provide direct feedback in real time and allows a step-by-step detailed check of the consistency of the data entered.In combination with the new digital biomarkers from dreams, the researchers hope to further optimize the individual assessment of the course of MS.
Dreams - Development and validation of digital biomarkers
Feasibility study (NCT 04413032/Recruitment underway)
Goal: Verification of usability, reproducibility, relevance for patients
Participants: 30 patients with MS and 30 healthy controls
Procedure: Participants will use the app for 6 weeks for 5-10 min/day on 5 days/week to complete a selection of small tasks ("challenges"). The data collected via App and Smartwatch will also be checked for reproducibility and compared with conventional tests collected at the baseline (clinical examination and neuropsychology). At the end of these 6 weeks the participants give their feedback regarding usability and usefulness in a questionnaire and an interview
Duration: 6 weeks/participant
Validation studies (planned from 2021)
Objective: Validation of the tests identified in the feasibility study as informative, reliable and user-friendly as digital biomarkers
Participants: 400 to 500 patients and some healthy control persons
Procedure: Digital biomarkers are longitudinally collected and compared with conventional test methods. The schedule is less intensive than in the first study to ensure longer-term adherence
Duration: min. 1 year / participant, target is 2 - 3 years / participant