Validating Digital Biomarkers to Detect Disease Activity and Disease Progression in Multiple Sclerosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MS Sherpa, Neurokeys.
- Who it may be relevant to
- Registry conditions: Multiple Sclerosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
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.
Primary outcome measures
- Impact of digital monitoring questionnaire: healthcare provider [Time frame: At each clinical consultation throughout the two year study follow-up]
- Adherence to the MS Sherpa application. [Time frame: Throughout the two year follow-up period. Assessments scheduled weekly.]
- Application outcomes of MS Sherpa [Time frame: Throughout the two year follow-up period. Assessments scheduled weekly.]
- Impact of digital monitoring questionnaire: patient [Time frame: At each clinical consultation throughout the two year study follow-up. Standard care is yearly clinical consultation.]
- Adherence to the Neurokeys application [Time frame: Daily passive monotring throughout the two year follow-up period.]
- Medical consumption questionnaire (iMCQ) [Time frame: At each clinical consultation throughout the two year study follow-up. Standard care is yearly clinical consultation.]
- Productivity costs questionnaire (iPCQ) [Time frame: At each clinical consultation throughout the two year study follow-up. Standard care is yearly clinical consultation.]
- Application outcomes of Neurokeys [Time frame: Continously and daily throughout the two year follow-up period.]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Netherlands · 3 centers
- Rijnstate Arnhem — Arnhem
- Zuyderland Medical Center — Geleen
- Amsterdam UMC — Amsterdam
Identifiers
NCT: NCT06627465 · 2024.0188