DreaMS - Validation Study 1

NCT05009160 | Active Not Recruiting

• 2 other identifiers: DreaMS_2021VS1SNCTP000004678
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Digital Biomarker

Outcome Measures

Primary Outcomes (2)

• Correlation of the digital features with the respective measurements of the clinical reference tests

  Spearman correlation coefficients higher than 0.4 (lower bound of 95% confidence interval) are considered relevant. All scheduled pairs of measurements collected during the study will be used. As the yearly observations of a patient are not independent, standard confidence intervals cannot be used. Therefore, a bootstrap approach will be used to determine a 95% confidence interval for the Spearman correlations (where data will be resampled on the patient level).

  Baseline to last visit (year two)

• The ability of measurements of the changes in the digital biomarkers over the two-year follow-up to predict worsening in the clinical reference test over the same period expressed as binary variables

  The change of the digital biomarker over two years allows to distinguish patients experiencing a relevant worsening in the corresponding reference test over the same period from those who do not with an area under the receiver operating characteristic curve (AUC) larger than 0.6 (lower bound of 95% confidence interval).

  Measurements at baseline and after two years

Study Arms (2)

Patients with Multiple Sclerosis (PwMS)

PwMS will download the Indivi platform App which contains the dreaMS App and will follow the study schedule.

Device: dreaMS App R2.1

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.

Device: dreaMS App R2.1

Interventions

dreaMS App R2.1 DEVICE

The Indivi 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); Patients with Multiple Sclerosis (PwMS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants of this study will be recruited from the outpatient department of the MS Center Basel at the University Hospital Basel.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: collaborator
• University of Basel: collaborator
• Innosuisse - Swiss Innovation Agency: collaborator
• Novartis Pharmaceuticals: collaborator
• Hoffmann-La Roche: collaborator
• Indivi AG: collaborator
• Research Center for Clinical Neuroimmunology and Neuroscience Basel: lead

Study Sites (6)

Neurozentrum, Kantonsspital Aarau

Aarau, Switzerland, Switzerland

Location

Department of Neurology, CHUV Lausanne

Lausanne, Switzerland, Switzerland

Location

Centro Sclerosi Multipla, Ospedale Regionale di Lugano

Lugano, Switzerland, Switzerland

Location

Klinik für Neurologie, Kantonsspital St. Gallen

Sankt Gallen, Switzerland, Switzerland

Location

Klinik für Neurologie, Universitätsspital Zürich

Zurich, Switzerland, Switzerland

Location

MS Center, Department of Neurology University Hospital Basel

Basel, Switzerland

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Ludwig Kappos

  Research Center for Clinical Neuroimmunology and Neuroscience Basel

  STUDY DIRECTOR

• Jannis Müller

  RC2NB and Department of Neurology, University Hospital of Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2021
• First Posted: August 17, 2021
• Study Start: March 30, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 10, 2026

Record last verified: 2026-02

Locations

CH (6)