Multiple Sclerosis (MS) is a chronic inflammatory disease of the central nervous system, characterized by a wide range of physical and cognitive symptoms. Clinical assessments, magnetic resonance imaging (MRI), and laboratory analyses form the basis of diagnosis and treatment decisions. However, traditional tools such as the Expanded Disability Status Scale (EDSS) have significant limitations. These include variability between examiners, insensitivity to subtle changes, and limited utility in tailoring individualized treatment strategies.

Digital biomarkers represent a promising new approach. Collected via smartphones, they include passive data (e.g., step count, sleep duration) and active performance-based measures (e.g., tests of walking, dexterity, or cognition). Because they are gathered frequently and in the patient’s natural environment, digital biomarkers can offer more granular, objective, and ecologically valid insights into disease progression.

The dreaMS VS1 study (NCT05009160) is an observational, longitudinal study embedded within the Swiss MS Cohort Study (SMSC). Included participants regularly complete selected dreaMS tasks on their smartphones according to a predefined schedule. These digital biomarkers are then compared to conventional clinical measures to assess their validity and predictive power, over a follow-up period of two years, with an optional one-year extension. The integration within the SMSC ensures high-quality, standardized clinical, imaging, and laboratory data, providing an ideal framework to evaluate the sensitivity of digital biomarkers to disease progression over time.

To accelerate recruitment and strengthen external validity, the study is being conducted across multiple SMSC sites, including Basel (coordinating center), Lugano (EOC), Lausanne (CHUV), Aarau (KSA), St. Gallen (KSG), and Zurich (USZ).