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DreaMS - Validation Study 1

NCT05009160 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2026-03-10

No results posted yet for this study

Summary

Multiple Sclerosis (MS) is a chronic inflammatory disease of the central nervous system (CNS) causing focal lesions of demyelination and diffuse neurodegeneration in the grey and white matter of the brain and spinal cord, leading to physical and cognitive disability. The scientific community and patients are in need for new and more reliable biomarkers, especially biomarkers of disease progression in order to adapt therapeutic approaches on an individual level. Digital biomarkers have the potential to fill this gap allowing for quasi-continuous measures that might be more informative than episodically collected conventional data concerning the impact of the disease on activities of daily living.

Using app-based challenges, continuous monitoring and surveys the Investigators aim to obtain data that can be used as digital biomarkers (DB). These digital biomarkers will provide more granular and precise assessments, thus complementing traditional diagnostic measures and techniques. After a first feasibility study (ClinicalTrials.gov: NCT04413032) a number of digital biomarkers have been identified as reliable, reproducible and meaningful to persons with MS (PwMS) and are therefore being validated in a bigger cohort of PwMS with a longer follow-up within this validation study 1. Those digital biomarkers will be compared to state-of-the-Art clinical, imaging and body fluid assessment.

Conditions

Interventions

DEVICE

dreaMS App R2.1

The Indivi platform App which contains the dreaMS App will be downloaded by all participants and all participants (PwMS and HC) will follow the same schedule

Sponsors & Collaborators

  • University Hospital, Basel, Switzerland

    collaborator OTHER

  • University of Basel

    collaborator OTHER

  • Innosuisse - Swiss Innovation Agency

    collaborator OTHER

  • Novartis Pharmaceuticals

    collaborator INDUSTRY

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • Indivi AG

    collaborator INDUSTRY

  • Research Center for Clinical Neuroimmunology and Neuroscience Basel

    lead OTHER

Principal Investigators

  • Ludwig Kappos · Research Center for Clinical Neuroimmunology and Neuroscience Basel

  • Jannis Müller · RC2NB and Department of Neurology, University Hospital of Basel, Switzerland

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-30
Primary Completion
2026-12-31
Completion
2027-03-31

Countries

  • Switzerland

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05009160 on ClinicalTrials.gov