Multiple Sclerosis (MS) is a chronic, inflammatory disease affecting the central nervous system. Diagnosis and treatment decisions for people with MS (PwMS) rely on clinical assessments, imaging, and body fluid evaluations. However, the current methods provide limited predictive value for individualizing treatments. Emerging digital measures, like the dreaMS software program developed by the Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB) in collaboration with Indivi, aim to offer more granular, continuous, and remote monitoring of disease progression. These digital tools are embedded in a mobile app and have shown promise in generating digital biomarkers (DB) that may enhance traditional MS assessments.

The main objective of the DreaMS VS2 study is to provide validated digital biomarkers that can be used for patient care, research, and regulatory decisions related to MS treatment. Beyond validation, the study aims to create a collaborative research platform for future studies and international academic partnerships. This research will contribute to more precise MS monitoring and treatment, improving the quality of life for PwMS by leveraging advanced digital health technologies.

The DreaMS VS2 study is an international research project designed to validate the digital biomarkers generated through the dreaMS software. It builds on the previous DreaMS VS1 study, which included more than 300 participants and assessed the clinical validity of candidate digital biomarkers (cDB) related to movement, balance, dexterity, vision, and cognition. The dreaMS VS2 study involves a larger international population, aiming to include approximately 600 patients from 21 centers in 11 countries. Its goal is to systematically replicate the results of VS1 while extending the evaluation to additional patient-relevant outcomes such as hospitalizations and quality of life. Sub-studies and deep phenotyping are included for more detailed analysis, and patients are actively involved in the study’s design and dissemination activities. RC2NB anticipates inclusion of the first patient in Q1 of 2026, with full study completion in 2030.