Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
300 participants
OBSERVATIONAL
2022-03-30
2027-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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 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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
DreaMS - Digital Biomarkers for Multiple Sclerosis
NCT04413032
Swiss Multiple Sclerosis Cohort-Study
NCT02433028
Development of Digital Biomarkers in Multiple Sclerosis: Validation Study 2
NCT06309173
Study to Evaluate the Usability and Value of Integrated Digital Solutions in Medical Care of Participants With Multiple Sclerosis
NCT05949580
Natalizumab De-escalation to Interferon-beta-1b in Patients With Relapsing-remitting Multiple Sclerosis
NCT01701856
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The Investigators have developed the Healios+Me platform App which contains the dreaMS App and serves as a data collection, communication and management platform using data collected through the patients' mobile devices (smartphone and wearables). Using the dreaMS 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 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patients with Multiple Sclerosis (PwMS)
PwMS will download the Indivi platform App which contains the dreaMS App and will follow the study schedule.
dreaMS App R2.1
The Healios+Me platform App which contains the dreaMS App will be downloaded by all participants and all participants (PwMS and HC) will follow the same schedule
Healthy Control Persons (HC)
HC will download the Indivi platform App which contains the dreaMS App and will follow the same study schedule as PwMS.
dreaMS App R2.1
The Healios+Me platform App which contains the dreaMS App will be downloaded by all participants and all participants (PwMS and HC) will follow the same schedule
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
dreaMS App R2.1
The Healios+Me platform App which contains the dreaMS App will be downloaded by all participants and all participants (PwMS and HC) will follow the same schedule
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Basel, Switzerland
OTHER
University of Basel
OTHER
Innosuisse - Swiss Innovation Agency
OTHER
Novartis Pharmaceuticals
INDUSTRY
Hoffmann-La Roche
INDUSTRY
Indivi AG
INDUSTRY
Research Center for Clinical Neuroimmunology and Neuroscience Basel
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ludwig Kappos
Role: STUDY_DIRECTOR
Research Center for Clinical Neuroimmunology and Neuroscience Basel
Jannis Müller
Role: PRINCIPAL_INVESTIGATOR
RC2NB and Department of Neurology, University Hospital of Basel, Switzerland
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Neurozentrum, Kantonsspital Aarau
Aarau, Switzerland, Switzerland
Department of Neurology, CHUV Lausanne
Lausanne, Switzerland, Switzerland
Centro Sclerosi Multipla, Ospedale Regionale di Lugano
Lugano, Switzerland, Switzerland
Klinik für Neurologie, Kantonsspital St. Gallen
Sankt Gallen, Switzerland, Switzerland
Klinik für Neurologie, Universitätsspital Zürich
Zurich, Switzerland, Switzerland
MS Center, Department of Neurology University Hospital Basel
Basel, , Switzerland
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SNCTP000004678
Identifier Type: REGISTRY
Identifier Source: secondary_id
DreaMS_2021VS1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.