Clinical trial NCT04413032: DreaMS - Digital Biomarkers for Multiple Sclerosis
Official title: DreaMS - Development of Digital Biomarkers in Multiple Sclerosis - Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Research Center for Clinical Neuroimmunology and Neuroscience Basel
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A group of patients with Multiple Sclerosis and a group of healthy volunteers will use the dreaMS App over the period of 6 weeks.
Primary purpose: OTHER

Brief summary: The Investigators have developed the dreaMS App, a data communication platform collecting data from the patients' mobile devices (smartphone and wearables). Through the use of app-based tests, surveys and sensor data, the Investigators aim to identify novel types of clinical data that can be used as digital biomarkers with complementary clinical value as compared to the traditional diagnostic methods and techniques.

In this feasibility study a number of digital biomarkers will be applied to test their technical reproducibility/stability and meaningfulness to patients.

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 patients with MS, 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 dreaMS App, a data communication platform collecting data from the patients' mobile devices (smartphone and wearables). Through the use of app-based tests, surveys and sensor data, the Investigators aim to identify novel types of clinical data that can be used as digital biomarkers with complementary clinical value as compared to the traditional diagnostic methods and techniques.

In this feasibility study a number of digital biomarkers will be applied to test their technical reproducibility/stability and meaningfulness to patients and to select the most informative for the planned validation study.

Eligibility criteria: Patients with MS

Inclusion Criteria:

* Age 18-70
* Diagnosed with MS according to the revised McDonald criteria 2017, all clinical forms inclusive (CIS, RRMS, SPMS, PPMS)
* EDSS ≤ 6.5
* In possession of a smart phone

Exclusion Criteria:

* Age \<18 and \> 70
* EDSS \> 6.5
* 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
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
* Women who are pregnant or breast feeding
* Not in possession of a smart phone

Healthy Volunteers

Inclusion Criteria:

* Age 18-70
* In possession of a smart phone

Exclusion Criteria:

* Age \<18 and \> 70
* Diagnosis of MS
* 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
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
* Women who are pregnant or breast feeding
* Not in possession of a smart phone

Primary outcomes:
measure: Test Reliability of digital biomarkers measured by Intra Class Correlation
timeFrame: 6 weeks
measure: Test Reliability of digital biomarkers measured by Coefficient of variation
timeFrame: 6 weeks
measure: Determination of user acceptance of each digital biomarker with regards to acceptance based on a questionnaire using a likert scale
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: RC2NB
Study officials:
affiliation: University Hospital Basel and RC2NB
name: Ludwig Kappos, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Woelfle T, Pless S, Reyes O, Wiencierz A, Feinstein A, Calabrese P, Gugleta K, Kappos L, Lorscheider J, Naegelin Y. Reliability and acceptance of dreaMS, a software application for people with multiple sclerosis: a feasibility study. J Neurol. 2023 Jan;270(1):262-271. doi: 10.1007/s00415-022-11306-5. Epub 2022 Aug 30.