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ACTIVE NOT RECRUITING
NCT05009160

DreaMS - Validation Study 1

Sponsor: Research Center for Clinical Neuroimmunology and Neuroscience Basel

View on ClinicalTrials.gov

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.

Official title: DreaMS - Development of Digital Biomarkers in Multiple Sclerosis - Validation Study 1

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

300

Start Date

2022-03-30

Completion Date

2027-03

Last Updated

2026-03-10

Healthy Volunteers

Yes

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

Locations (6)

Neurozentrum, Kantonsspital Aarau

Aarau, Switzerland, Switzerland

Department of Neurology, CHUV Lausanne

Lausanne, Switzerland, Switzerland

Centro Sclerosi Multipla, Ospedale Regionale di Lugano

Lugano, Switzerland, Switzerland

Klinik für Neurologie, Kantonsspital St. Gallen

Sankt Gallen, Switzerland, Switzerland

Klinik für Neurologie, Universitätsspital Zürich

Zurich, Switzerland, Switzerland

MS Center, Department of Neurology University Hospital Basel

Basel, Switzerland