Development of Digital Biomarkers in Multiple Sclerosis: Validation Study 2

Withdrawn before enrolling

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT06309173

Run by

Research Center for Clinical Neuroimmunology and Neuroscience Basel

People needed

0

Starts

2026-05-01

Expected to finish

2029-12-01

Last updated by the study team

2026-04-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥18
• Diagnosed with MS according to the revised McDonald criteria 2017, all clinical forms inclusive (CIS, RRMS, SPMS, PPMS)
• In possession of a Healios+Me app-compatible smartphone (iOS/Android)
• Corrected close visual acuity of ≥0.5
• Hand motor skills sufficient for using a smartphone
• Ability and intention to follow the study procedures
• Sufficient knowledge of the language for the specific country
• Informed Consent as documented by signature

You may not qualify if…

• NA

Where it is running

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

Full record on ClinicalTrials.gov

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