Clinical trial NCT05009160: DreaMS - Validation Study 1
Official title: DreaMS - Development of Digital Biomarkers in Multiple Sclerosis - Validation Study 1
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Digital Biomarker
Lead sponsor: Research Center for Clinical Neuroimmunology and Neuroscience Basel
Sponsor class: OTHER
Collaborators: name: University Hospital, Basel, Switzerland
name: University of Basel
name: Innosuisse - Swiss Innovation Agency
name: Novartis Pharmaceuticals
name: Hoffmann-La Roche
name: Indivi AG
First posted: 2021-08-17
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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 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.

Detailed description: 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. Currently there is a limited number of relevant biomarkers available in persons with MS (PwMS), such as clinical, imaging or biological measures. Patient history and neurologic examination in combination with magnetic resonance imaging (MRI), evoked potentials and analysis of serum and cerebrospinal fluid (CSF) are the gold standard of diagnosis and mainly patient history, neurologic examination and MRI are used for patient monitoring. However, their prognostic value on a patient level is still very limited. Therefore, 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.

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.

Eligibility 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

Primary outcomes:
measure: Correlation of the digital features with the respective measurements of the clinical reference tests
timeFrame: Baseline to last visit (year two)
measure: 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
timeFrame: Measurements at baseline and after two years
Secondary outcomes:
Other outcomes:
Locations:
city: Aarau
country: Switzerland
facility: Neurozentrum, Kantonsspital Aarau
city: Basel
country: Switzerland
facility: MS Center, Department of Neurology University Hospital Basel
city: Lausanne
country: Switzerland
facility: Department of Neurology, CHUV Lausanne
city: Lugano
country: Switzerland
facility: Centro Sclerosi Multipla, Ospedale Regionale di Lugano
city: St.Gallen
country: Switzerland
facility: Klinik für Neurologie, Kantonsspital St. Gallen
city: Zürich
country: Switzerland
facility: Klinik für Neurologie, Universitätsspital Zürich
Study officials:
affiliation: Research Center for Clinical Neuroimmunology and Neuroscience Basel
name: Ludwig Kappos
role: STUDY_DIRECTOR
affiliation: RC2NB and Department of Neurology, University Hospital of Basel, Switzerland
name: Jannis Müller
role: PRINCIPAL_INVESTIGATOR
References: