Development of Digital Biomarkers in Multiple Sclerosis: Validation Study 2

Official Summary

Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system (CNS). Diagnosis is established by clinical assessment of persons with MS (PwMS), in combination with imaging and body fluid assessments. Treatment decisions in MS are mainly based on periodic monitoring of disease activity and progression through clinical and imaging assessments. The predictive and prognostic value of currently used assessments to individualize treatment decisions is still very limited. Emerging digital measures have the potential to provide granular health status measurements that would allow monitoring MS disease activity and progression continuously and remotely, in real-world settings, with minimal disruption of patients' life. Using the investigators' self developed dreaMS software program the investigators previously identified digital biomarkers (DB) that hold promise to provide detailed and accurate assessments of MS-related health status and disease progression to complement traditional clinical, imaging, or body fluid assessments. This international, observational study aims to evaluate and validate the generalizability of these DB across different languages and cultural settings to provide DB that are helpful for patient care, research, and regulatory decisions. Beyond this, the processes and data structures created for this study are intended to establish a collaborative research platform for subsequent studies, including pragmatic trials, promoting new long-term international academic collaborations.

Study Design

• Study Type: OBSERVATIONAL

Primary Outcomes

• Correlation of the digital features with the respective measurements of the clinical reference tests (Baseline, 12 months, 24 months)
• The ability of measurements of the changes in the digital biomarkers over the two-year follow-up to predict worsening in the clinical reference test over the same period expressed as binary variables (Baseline and 24 months)

Secondary Outcomes

• The ability of the digital biomarker to detect worsening in other relevant reference test results creating converging evidence (up to 24 months)
• The ability of the digital biomarker to detect worsening in standard assessments used for treatment of PwMS (clinical, imaging, body fluids) (up to 24 months)
• The ability of the digital biomarker to detect change of Patient Reported Outcomes (up to 24 months)
• The ability of the digital biomarker to detect occurrence of clinical and other meaningful events (relapses, PIRA, serious adverse events, hospitalizations, working capacity) (up to 24 months)
• The relationship of the digital biomarkers with imaging and body fluid markers (up to 24 months)

Trial Locations

• University of California, San Francisco (UCSF) Weill Institute, Department of Neurology, San Francisco, California, United States
• Innsbruck Medical University, Department of Neurology, Innsbruck, Tyrol, Austria
• Vienna Medical University, Department of Neurology, Vienna, Vienna, Austria

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