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

NCT ID: NCT06627465

Last Updated: 2024-10-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-15
• Study Completion Date: 2028-01-01

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amsterdam UMC, location VUmc

OTHER

Sponsor Role: lead

Responsible Party

Joep Killestein

Prinicipal Investigator, Clinical Professor, Head of the MS Center Amsterdam

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joep Killestein, Prof

Role: PRINCIPAL_INVESTIGATOR

Amsterdam UMC

Eva Strijbis, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Amsterdam UMC

Locations

Rijnstate Arnhem

Arnhem, Gelderland, Netherlands

Zuyderland Medical Center

Geleen, Limburg, Netherlands

Amsterdam UMC

Amsterdam, North Holland, Netherlands

Countries

Netherlands

Central Contacts

Daan de Jong, MD MSc

Role: CONTACT

connectms@amsterdamumc.nl

+31625716307

Eva Strijbis, MD PhD

Role: CONTACT

connectms@amsterdamumc.nl

+31625716307

Facility Contacts

Jop Mostert, MD PhD

Role: primary

Oliver Gerlach, MD PhD

Role: primary

Daan de Jong, MD

Role: primary

Other Identifiers

2024.0188

Identifier Type: -

Identifier Source: org_study_id