<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/NCT04438967</url>
  </required_header>
  <id_info>
    <org_study_id>MIRO_001_2020</org_study_id>
    <nct_id>NCT04438967</nct_id>
  </id_info>
  <brief_title>Brain Health in the Time of COVID-19</brief_title>
  <official_title>Brain Health in the Time of COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Miro Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Miro Health</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a nationwide research program to study the neurological effects of COVID-19. It is&#xD;
      open to the public. Healthy individuals and individuals who are or have been infected with&#xD;
      COVID-19 are encouraged to join the effort. The study can be done at home with internet&#xD;
      access and an iPad or iPhone. Participation takes about one hour.&#xD;
&#xD;
      To learn more, go to https://www.mirohealth.com/consent/&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Neurological complications have been reported in patients with COVID-19. To better understand&#xD;
      neurological complications, a group of research hospitals are collaborating to track&#xD;
      neurological outcomes. We know that COVID-19 can invade our nervous system, but little is&#xD;
      known about the range of effects that COVID-19 might have on the brain. This study aims to&#xD;
      gain real-time information about the neurological health of the U.S. population to advance&#xD;
      knowledge of COVID-19.&#xD;
&#xD;
      At the conclusion of the study, you will receive non-medical information on your brain&#xD;
      function as well as study findings and publications made possible by your participation. With&#xD;
      your permission, Miro Health can also release the results of your assessment to your&#xD;
      physician. In order for Miro Health to do this, you will be required to confirm your identity&#xD;
      online, sign a HIPAA agreement to share the information with your physician, and to enter&#xD;
      your physician's name, email, and contact information. Study duration will depend on the&#xD;
      development of the COVID-19 pandemic.&#xD;
&#xD;
      To participate, you must submit a valid email. No other personally identifiable information&#xD;
      will be gathered at this time.&#xD;
&#xD;
      To participate, you will:&#xD;
&#xD;
      Answer online questions Answer a few questions about your health Download the Miro Health app&#xD;
      from the iTunes store Open the app and complete Miro's interactive tasks (30 mins)&#xD;
&#xD;
      Advisory: Should you feel that you have symptoms related to COVID-19, contact your healthcare&#xD;
      provider or local community health office. Miro Health cannot provide healthcare assistance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 16, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Test the hypothesis that COVID-19 infection will lead to increased risk of neurological impairment</measure>
    <time_frame>~1 year</time_frame>
    <description>Each participant's Risk Score of mild cognitive impairment will be calculated using machine learning methods on a percent range of 0-100%. Miro Mobile Assessments will measure each individual's functional performance in neurocognitive, neurobehavioral, motor, and emotional domains. Miro Mobile is a clinically-validated iPad application in use by Johns Hopkins and other research centers. Miro Questionnaires will gather each individual's demographic data. To learn more, go to https://www.mirohealth.com/consent/&#xD;
Miro Functional Assessments evaluate:&#xD;
Attention Executive function Learning and Memory Motor function Processing speed Speech and language Visuospatial function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Determine cognitive and behavioral functional patterns that predict susceptibility to neurological impairment due to COVID-19</measure>
    <time_frame>~1 year</time_frame>
    <description>Miro Questionnaires will gather each individual's demographic and medical history data. Miro Mobile Assessments will measure each individual's CNS functional performance.&#xD;
From this data, Miro will test the hypothesis that health indicators exist that can predict the likelihood of a COVID-19 infection leading to neurological impairment.&#xD;
Miro Functional Assessments evaluate:&#xD;
Attention Executive function Learning and Memory Motor function Processing speed Speech and language Visuospatial function</description>
  </primary_outcome>
  <enrollment type="Anticipated">10000</enrollment>
  <condition>Brain Health</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Study population is open to anyone over the age of 18 who can consent for themself.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Access to an iPad bought in 2013 or later&#xD;
&#xD;
          -  Access to stable Wi-Fi&#xD;
&#xD;
          -  Access to iTunes&#xD;
&#xD;
        Exclusion Criteria for healthy:&#xD;
&#xD;
          -  Below age 18&#xD;
&#xD;
          -  Preexisting neurological, psychiatric, or developmental disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Natasha Belfor, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Miro Health</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Leah Rubin, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Natasha Belfor, PhD</last_name>
    <phone>415-655-3839</phone>
    <email>research@mirohealth.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Miro Health</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94107</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shenly Glenn, BS</last_name>
      <phone>415-317-3939</phone>
      <email>research@mirohealth.com</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7151535/</url>
    <description>Asadi-Pooya &amp; Simani 2020; Leonardi et al., 2020, Wu et al., 2020</description>
  </link>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>January 4, 2021</last_update_submitted>
  <last_update_submitted_qc>January 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>neurocognitive</keyword>
  <keyword>stroke</keyword>
  <keyword>nervous system</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04438967
org study id: MIRO_001_2020
nct id: NCT04438967
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This is a nationwide research program to study the neurological effects of COVID-19. It is
      open to the public. Healthy individuals and individuals who are or have been infected with
      COVID-19 are encouraged to join the effort. The study can be done at home with internet
      access and an iPad or iPhone. Participation takes about one hour.

      To learn more, go to https://www.mirohealth.com/consent/
Neurological complications have been reported in patients with COVID-19. To better understand
      neurological complications, a group of research hospitals are collaborating to track
      neurological outcomes. We know that COVID-19 can invade our nervous system, but little is
      known about the range of effects that COVID-19 might have on the brain. This study aims to
      gain real-time information about the neurological health of the U.S. population to advance
      knowledge of COVID-19.

      At the conclusion of the study, you will receive non-medical information on your brain
      function as well as study findings and publications made possible by your participation. With
      your permission, Miro Health can also release the results of your assessment to your
      physician. In order for Miro Health to do this, you will be required to confirm your identity
      online, sign a HIPAA agreement to share the information with your physician, and to enter
      your physician's name, email, and contact information. Study duration will depend on the
      development of the COVID-19 pandemic.

      To participate, you must submit a valid email. No other personally identifiable information
      will be gathered at this time.

      To participate, you will:

      Answer online questions Answer a few questions about your health Download the Miro Health app
      from the iTunes store Open the app and complete Miro's interactive tasks (30 mins)

      Advisory: Should you feel that you have symptoms related to COVID-19, contact your healthcare
      provider or local community health office. Miro Health cannot provide healthcare assistance.
observational model: Cohort
time perspective: Other
measure: Test the hypothesis that COVID-19 infection will lead to increased risk of neurological impairment
time frame: ~1 year
description: Each participant's Risk Score of mild cognitive impairment will be calculated using machine learning methods on a percent range of 0-100%. Miro Mobile Assessments will measure each individual's functional performance in neurocognitive, neurobehavioral, motor, and emotional domains. Miro Mobile is a clinically-validated iPad application in use by Johns Hopkins and other research centers. Miro Questionnaires will gather each individual's demographic data. To learn more, go to https://www.mirohealth.com/consent/
Miro Functional Assessments evaluate:
Attention Executive function Learning and Memory Motor function Processing speed Speech and language Visuospatial function
measure: Determine cognitive and behavioral functional patterns that predict susceptibility to neurological impairment due to COVID-19
time frame: ~1 year
description: Miro Questionnaires will gather each individual's demographic and medical history data. Miro Mobile Assessments will measure each individual's CNS functional performance.
From this data, Miro will test the hypothesis that health indicators exist that can predict the likelihood of a COVID-19 infection leading to neurological impairment.
Miro Functional Assessments evaluate:
Attention Executive function Learning and Memory Motor function Processing speed Speech and language Visuospatial function
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Natasha Belfor, PhD
role: Principal Investigator
affiliation: Miro Health
last name: Leah Rubin, PhD
role: Principal Investigator
affiliation: Johns Hopkins University
last name: Natasha Belfor, PhD
phone: 415-655-3839
email: research@mirohealth.com
facility: 
status: Recruiting
contact: 
country: United States
url: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7151535/
description: Asadi-Pooya & Simani 2020; Leonardi et al., 2020, Wu et al., 2020
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: Yes