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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Device
Study Type: Observational
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Age ≥18

• Diagnosed with MS according to the revised McDonald criteria 2017, all clinical forms inclusive (CIS, RRMS, SPMS, PPMS), for PwMS only

• 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 to follow the study procedures

• Informed Consent as documented by signature

Locations
Other Locations
Switzerland
Neurozentrum, Kantonsspital Aarau
RECRUITING
Aarau
MS Center, Department of Neurology University Hospital Basel
RECRUITING
Basel
Department of Neurology, CHUV Lausanne
RECRUITING
Lausanne
Centro Sclerosi Multipla, Ospedale Regionale di Lugano
RECRUITING
Lugano
Klinik für Neurologie, Kantonsspital St. Gallen
RECRUITING
Sankt Gallen
Klinik für Neurologie, Universitätsspital Zürich
RECRUITING
Zurich
Contact Information
Primary
Jannis Müller
jannis.mueller@usb.ch
+41613284345
Time Frame
Start Date: 2022-03-30
Estimated Completion Date: 2027-03
Participants
Target number of participants: 300
Treatments
Patients with Multiple Sclerosis (PwMS)
PwMS will download the Indivi platform App which contains the dreaMS App and will follow the study schedule.
Healthy Control Persons (HC)
HC will download the Indivi platform App which contains the dreaMS App and will follow the same study schedule as PwMS.
Related Therapeutic Areas
Sponsors
Collaborators: Hoffmann-La Roche, Indivi AG, Novartis Pharmaceuticals, Innosuisse - Swiss Innovation Agency, University of Basel, University Hospital, Basel, Switzerland
Leads: Research Center for Clinical Neuroimmunology and Neuroscience Basel

This content was sourced from clinicaltrials.gov