DreaMS - Digital Biomarkers for Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

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.
    

Intervention name(s): DreaMS
Intervention type(s): Device
Intervention description(s): 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.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
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.
Masking: None (Open Label)
Primary purpose: Other