<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04413032</url>
  </required_header>
  <id_info>
    <org_study_id>DreaMS_2020F</org_study_id>
    <nct_id>NCT04413032</nct_id>
  </id_info>
  <brief_title>DreaMS - Digital Biomarkers for Multiple Sclerosis</brief_title>
  <acronym>DreaMS</acronym>
  <official_title>DreaMS - Development of Digital Biomarkers in Multiple Sclerosis - Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Research Center for Clinical Neuroimmunology and Neuroscience Basel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Research Center for Clinical Neuroimmunology and Neuroscience Basel</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Investigators have developed the dreaMS App, a data communication platform collecting&#xD;
      data from the patients' mobile devices (smartphone and wearables). Through the use of&#xD;
      app-based tests, surveys and sensor data, the Investigators aim to identify novel types of&#xD;
      clinical data that can be used as digital biomarkers with complementary clinical value as&#xD;
      compared to the traditional diagnostic methods and techniques.&#xD;
&#xD;
      In this feasibility study a number of digital biomarkers will be applied to test their&#xD;
      technical reproducibility/stability and meaningfulness to patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Multiple Sclerosis (MS) is a chronic inflammatory disease of the central nervous system (CNS)&#xD;
      causing focal lesions of demyelination and diffuse neurodegeneration in the grey and white&#xD;
      matter of the brain and spinal cord, leading to physical and cognitive disability. Currently&#xD;
      there is a limited number of relevant biomarkers available in patients with MS, such as&#xD;
      clinical, imaging or biological measures. Patient history and neurologic examination in&#xD;
      combination with magnetic resonance imaging (MRI), evoked potentials and analysis of serum&#xD;
      and cerebrospinal fluid (CSF) are the gold standard of diagnosis and mainly patient history,&#xD;
      neurologic examination and MRI are used for patient monitoring. However, their prognostic&#xD;
      value on a patient level is still very limited. Therefore, the scientific community and&#xD;
      patients are in need for new and more reliable biomarkers, especially biomarkers of disease&#xD;
      progression in order to adapt therapeutic approaches on an individual level. Digital&#xD;
      biomarkers have the potential to fill this gap allowing for quasi-continuous measures that&#xD;
      might be more informative than episodically collected conventional data concerning the impact&#xD;
      of the disease on activities of daily living.&#xD;
&#xD;
      The Investigators have developed the dreaMS App, a data communication platform collecting&#xD;
      data from the patients' mobile devices (smartphone and wearables). Through the use of&#xD;
      app-based tests, surveys and sensor data, the Investigators aim to identify novel types of&#xD;
      clinical data that can be used as digital biomarkers with complementary clinical value as&#xD;
      compared to the traditional diagnostic methods and techniques.&#xD;
&#xD;
      In this feasibility study a number of digital biomarkers will be applied to test their&#xD;
      technical reproducibility/stability and meaningfulness to patients and to select the most&#xD;
      informative for the planned validation study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 5, 2020</start_date>
  <completion_date type="Actual">February 26, 2021</completion_date>
  <primary_completion_date type="Actual">February 26, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <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.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Test Reliability of digital biomarkers measured by Intra Class Correlation</measure>
    <time_frame>6 weeks</time_frame>
    <description>Number of digital biomarkers tested with an Intra Class Correlation of at least 0.6 if repeated 10 times</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Test Reliability of digital biomarkers measured by Coefficient of variation</measure>
    <time_frame>6 weeks</time_frame>
    <description>Number of digital biomarkers tested with a coefficient of Variation of less than 20% if repeated 10 times</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Determination of user acceptance of each digital biomarker with regards to acceptance based on a questionnaire using a likert scale</measure>
    <time_frame>6 weeks</time_frame>
    <description>Number of digital biomarkers tested with a good acceptance reflected by a mean response of more than 3 on a likert scale.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">62</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Patients with MS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>30 Patients with MS will use the DreaMS App over a study duration of 6 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Volunteers</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>30 Healthy Volunteers will use the DreaMS App over a study duration of 6 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>DreaMS</intervention_name>
    <description>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.</description>
    <arm_group_label>Healthy Volunteers</arm_group_label>
    <arm_group_label>Patients with MS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Patients with MS&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-70&#xD;
&#xD;
          -  Diagnosed with MS according to the revised McDonald criteria 2017, all clinical forms&#xD;
             inclusive (CIS, RRMS, SPMS, PPMS)&#xD;
&#xD;
          -  EDSS ≤ 6.5&#xD;
&#xD;
          -  In possession of a smart phone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;18 and &gt; 70&#xD;
&#xD;
          -  EDSS &gt; 6.5&#xD;
&#xD;
          -  Other clinically significant concomitant disease states (e.g., renal failure, severe&#xD;
             hepatic dysfunction, severe/unstable cardiovascular disease, progressive cancer, etc.)&#xD;
&#xD;
          -  Known or suspected non-compliance, drug or alcohol abuse&#xD;
&#xD;
          -  Inability to follow the procedures of the study, e.g. due to language problems,&#xD;
             psychological disorders, dementia, etc.&#xD;
&#xD;
          -  Women who are pregnant or breast feeding&#xD;
&#xD;
          -  Not in possession of a smart phone&#xD;
&#xD;
        Healthy Volunteers&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-70&#xD;
&#xD;
          -  In possession of a smart phone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;18 and &gt; 70&#xD;
&#xD;
          -  Diagnosis of MS&#xD;
&#xD;
          -  Clinically significant concomitant disease states (e.g., renal failure, severe hepatic&#xD;
             dysfunction, severe/unstable cardiovascular disease, progressive cancer, etc.)&#xD;
&#xD;
          -  Known or suspected non-compliance, drug or alcohol abuse&#xD;
&#xD;
          -  Inability to follow the procedures of the study, e.g. due to language problems,&#xD;
             psychological disorders, dementia, etc.&#xD;
&#xD;
          -  Women who are pregnant or breast feeding&#xD;
&#xD;
          -  Not in possession of a smart phone&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ludwig Kappos, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Basel and RC2NB</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>RC2NB</name>
      <address>
        <city>Basel</city>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>May 12, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>March 1, 2021</last_update_submitted>
  <last_update_submitted_qc>March 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04413032
org study id: DreaMS_2020F
nct id: NCT04413032
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
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.
primary purpose: Other
masking: None (Open Label)
measure: Test Reliability of digital biomarkers measured by Intra Class Correlation
time frame: 6 weeks
description: Number of digital biomarkers tested with an Intra Class Correlation of at least 0.6 if repeated 10 times
measure: Test Reliability of digital biomarkers measured by Coefficient of variation
time frame: 6 weeks
description: Number of digital biomarkers tested with a coefficient of Variation of less than 20% if repeated 10 times
measure: Determination of user acceptance of each digital biomarker with regards to acceptance based on a questionnaire using a likert scale
time frame: 6 weeks
description: Number of digital biomarkers tested with a good acceptance reflected by a mean response of more than 3 on a likert scale.
arm group label: Patients with MS
arm group type: Experimental
description: 30 Patients with MS will use the DreaMS App over a study duration of 6 weeks.
arm group label: Healthy Volunteers
arm group type: Experimental
description: 30 Healthy Volunteers will use the DreaMS App over a study duration of 6 weeks.
intervention type: Device
intervention name: DreaMS
description: 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.
arm group label: Healthy Volunteers
arm group label: Patients with MS
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ludwig Kappos, MD
role: Principal Investigator
affiliation: University Hospital Basel and RC2NB
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Multiple Sclerosis
mesh term: Sclerosis