NCT05009160Active, not recruiting
DreaMS - Validation Study 1
DreaMS - Development of Digital Biomarkers in Multiple Sclerosis - Validation Study 1
Source: ClinicalTrials.gov · Last updated 10 Mar 2026
Brief summary (registry, in English)
Multiple Sclerosis (MS) is a chronic inflammatory disease of the central nervous system (CNS) causing focal lesions of demyelination and diffuse neurodegeneration in the grey and white matter of the brain and spinal cord, leading to physical and cognitive disability. The scientific community and patients are in need for new and more reliable biomarkers, especially biomarkers of disease progression in order to adapt therapeutic approaches on an individual level. Digital biomarkers have the potential to fill this gap allowing for quasi-continuous measures that might be more informative than episodically collected conventional data concerning the impact of the disease on activities of daily living. Using app-based challenges, continuous monitoring and surveys the Investigators aim to obtain data that can be used as digital biomarkers (DB). These digital biomarkers will provide more granular and precise assessments, thus complementing traditional diagnostic measures and techniques. After a first feasibility study (ClinicalTrials.gov: NCT04413032) a number of digital biomarkers have been identified as reliable, reproducible and meaningful to persons with MS (PwMS) and are therefore being validated in a bigger cohort of PwMS with a longer follow-up within this validation study 1. Those digital biomarkers will be compared to state-of-the-Art clinical, imaging and body fluid assessment.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 23 Jul 2021
- Start date
- Mar 2022
- Primary completion date
- Dec 2026
- Lead sponsor
- Research Center for Clinical Neuroimmunology and Neuroscience Basel
- Diseases
- Multiple sclerosis
- NCT number
- NCT05009160
What you commit to
- Study type: Observational
- Planned participants: 300
- From Mar 2022 to the primary completion date, Dec 2026
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Being diagnosed with MS or other disease affecting neurological and cognitive functions, for HC only
Who the study is looking for
- 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 Indivi 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Neurozentrum, Kantonsspital Aarau Coordinator of this site? Confirm its status | Aarau | Switzerland | Unknown status |
| MS Center, Department of Neurology University Hospital Basel Coordinator of this site? Confirm its status | Basel | Switzerland | Unknown status |
| Department of Neurology, CHUV Lausanne Coordinator of this site? Confirm its status | Lausanne | Switzerland | Unknown status |
| Centro Sclerosi Multipla, Ospedale Regionale di Lugano Coordinator of this site? Confirm its status | Lugano | Switzerland | Unknown status |
| Klinik für Neurologie Kantonsspital St.Gallen Coordinator of this site? Confirm its status | Sankt Gallen | Switzerland | Unknown status |
| Klinik für Neurologie, Universitätsspital Zürich Coordinator of this site? Confirm its status | Zurich | Switzerland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.