Validation of digital biomarkers for Multiple Sclerosis
DreaMS - Development of Digital Biomarkers in Multiple Sclerosis - Validation Study 1
This study is testing a new app that uses digital tools to track and understand how Multiple Sclerosis affects people, hoping to create better ways to personalize treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Research Center for Clinical Neuroimmunology and Neuroscience Basel Academic / other |
| Locations | 6 sites (Aarau and 5 other locations) |
| Trial ID | NCT05009160 on ClinicalTrials.gov |
What this trial studies
This study aims to validate digital biomarkers for Multiple Sclerosis (MS) using the Healios+Me platform App, which collects data through app-based challenges, continuous monitoring, and surveys. By leveraging mobile devices and wearables, the study seeks to provide more granular and precise assessments of disease progression compared to traditional diagnostic measures. The goal is to develop reliable biomarkers that can inform individualized therapeutic approaches for patients with MS.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with any form of Multiple Sclerosis.
Not a fit: Patients with other diseases affecting neurological and cognitive functions or those with significant concomitant diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate monitoring and management of Multiple Sclerosis, improving patient outcomes.
How similar studies have performed: Other studies have shown promise in using digital biomarkers for chronic conditions, indicating potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 * Diagnosed with MS according to the revised McDonald criteria 2017, all clinical forms inclusive (CIS, RRMS, SPMS, PPMS), for PwMS only * In possession of a Healios+Me App compatible smartphone (iOS/Android) * Corrected close visual acuity of ≥0.5 * Hand motor skills sufficient for using a smartphone * Ability to follow the study procedures * Informed Consent as documented by signature Exclusion Criteria: * Being diagnosed with MS or other disease affecting neurological and cognitive functions, for HC only * Other clinically significant concomitant disease states (e.g., renal failure, severe hepatic dysfunction, severe/unstable cardiovascular disease, progressive cancer, etc.) * Known or suspected non-compliance, drug or alcohol abuse
Where this trial is running
Aarau and 5 other locations
- Neurozentrum, Kantonsspital Aarau — Aarau, Switzerland (Recruiting)
- MS Center, Department of Neurology University Hospital Basel — Basel, Switzerland (Recruiting)
- Department of Neurology, CHUV Lausanne — Lausanne, Switzerland (Recruiting)
- Centro Sclerosi Multipla, Ospedale Regionale di Lugano — Lugano, Switzerland (Recruiting)
- Klinik für Neurologie, Kantonsspital St. Gallen — St.Gallen, Switzerland (Recruiting)
- Klinik für Neurologie, Universitätsspital Zürich — Zürich, Switzerland (Recruiting)
Study contacts
- Principal investigator: Jannis Müller — RC2NB and Department of Neurology, University Hospital of Basel, Switzerland
- Study coordinator: Jannis Müller
- Email: jannis.mueller@usb.ch
- Phone: +41613284345
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.