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NOT YET RECRUITING
NCT06627465

Validating Digital Biomarkers to Detect Disease Activity and Disease Progression in Multiple Sclerosis

Sponsor: Amsterdam UMC, location VUmc

View on ClinicalTrials.gov

Summary

The Connect-MS is multicentre real-world observational cohort study wherin the outcomes of standard care digital monitoring of 700 patients with multiple sclerosis (including all subtypes) are recorded over a follow-up period of two years. Patients use the MS sherpa and NeuroKeys applications. Outcomes are related to the utilisation of digital biomarkers including the adherence to digital monitoring and the impact digital outcomes have on clinical decision making, the effect of digital monitoring on healthcare consumption, and the ability of these technological biomarkers to detect clinical outcomes on the short and long term. Most recorded variables are part of the standard care, however participants of this study are also subject to additional questionnaires regarding the consumption of healthcare and the influence of digital monitoring on decision making during clinical consultation.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

600

Start Date

2024-10-15

Completion Date

2028-01-01

Last Updated

2024-10-04

Healthy Volunteers

No

Interventions

DEVICE

MS Sherpa

The MS Sherpa application is a CE-certified smartphone application (installed on the mobile phone of the patient) that collects digital biomarkers using tests (\~six minutes/test: self-monitoring questionnaires, smartphone 2-MWT, and a smartphone SDMT) once per week in the home environment of the patient.

DEVICE

Neurokeys

The NeuroKeys application is a CE-certified application (installed on the mobile phone of the patient) that passively and continuously monitors keystroke dynamics of everyday typing as a digital biomarker.

Locations (3)

Rijnstate Arnhem

Arnhem, Gelderland, Netherlands

Zuyderland Medical Center

Geleen, Limburg, Netherlands

Amsterdam UMC

Amsterdam, North Holland, Netherlands