Development of Digital Biomarkers in Multiple Sclerosis: Validation Study 2
Key facts
- Who runs it
- Research Center for Clinical Neuroimmunology and Neuroscience Basel
- Where
- San Francisco, United StatesSee the siteAlso in 1 other country, 2 sites
- Trial code
- Status
- Withdrawn
- Started
- May 2026
- Expected to end
- Dec 2029
- Type of study
- Observational
- Record updated
- 1 April 2026
- Why it stopped
- The study was terminated prior to first patient enrollment based on strategic considerations.
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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
Who cannot take part
- NA
Where in United States
Also in 1 other country, 2 sites
- University of California, San Francisco (UCSF) Weill Institute, Department of NeurologySan Francisco, United States
About the trial
What the trial wants to find out
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.
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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.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 1 April 2026