NCT06627465

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Amsterdam UMC, location VUmc · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-10-15
• Primary completion: 2026-01-01
• Completion: 2028-01-01
• First posted: 2024-10-04
• Last updated: 2024-10-04

Locations

3 sites across 1 country: Netherlands