Validating Digital Biomarkers to Detect Disease Activity and Disease Progression in Multiple Sclerosis (Connect-MS)

Amsterdam UMC, location VUmc

Status: Not yet enrolling

Conditions: Multiple Sclerosis

Treatments: Device: Neurokeys; Device: MS Sherpa

Study type: Observational

Funder types: Other

Identifiers

NCT06627465

2024.0188

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

• Have signed non-WMO informed consent
• Be able to comply with the study protocol, as judged by the investigator.
• Have a minimum age of 18 years.
• Have a definite diagnosis multiple sclerosis (either RRMS, SPMS or PPMS) according to the revised 2017 McDonald criteria. (Thompson et al., 2018)
• Willing and able to install and use MS Sherpa and NeuroKeys on a privately-owned cell phone.

Since this is an observational cohort study, concomitant participation in any intervention trial is allowed.