NCT04413032

DreaMS - Digital Biomarkers for Multiple Sclerosis

DreaMS - Development of Digital Biomarkers in Multiple Sclerosis - Feasibility Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Research Center for Clinical Neuroimmunology and Neuroscience Basel · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DEVICE	DreaMS	The dreaMS App is a data communication platform collecting data from the patients' mobile devices (smartphone and wearables). We analyze app-based tests, surveys and sensor data.

Timeline

• Start date: 2020-10-05
• Primary completion: 2021-02-26
• Completion: 2021-02-26
• First posted: 2020-06-02
• Last updated: 2021-03-02

Locations

1 site across 1 country: Switzerland