Brain Health in the Time of COVID-19

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/

Study Overview

• Status: Unknown
• Conditions: Brain Health

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 10000

Contacts and Locations

• Study Contact: Name: Natasha Belfor, PhD; Phone Number: 415-655-3839; Email: research@mirohealth.com

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94107
      • Recruiting
      • Miro Health
      • Contact: Shenly Glenn, BS; Phone Number: 415-317-3939; Email: research@mirohealth.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Study population is open to anyone over the age of 18 who can consent for themself.

Description

Inclusion Criteria:

• 18 years of age or older
• Access to an iPad bought in 2013 or later
• Access to stable Wi-Fi
• Access to iTunes

Exclusion Criteria for healthy:

• Below age 18
• Preexisting neurological, psychiatric, or developmental disorder

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Test the hypothesis that COVID-19 infection will lead to increased risk of neurological impairment	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	~1 year
Determine cognitive and behavioral functional patterns that predict susceptibility to neurological impairment due to COVID-19	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	~1 year

Collaborators and Investigators

• Sponsor: Miro Health
• Collaborators: Johns Hopkins University; University of Pittsburgh
• Investigators: Principal Investigator: Natasha Belfor, PhD, Miro Health

Publications and helpful links

Helpful Links

• Asadi-Pooya & Simani 2020; Leonardi et al., 2020, Wu et al., 2020

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 16, 2020
• Primary Completion (ANTICIPATED): December 31, 2021
• Study Completion (ANTICIPATED): December 31, 2021

Study Registration Dates

• First Submitted: June 15, 2020
• First Submitted That Met QC Criteria: June 17, 2020
• First Posted (ACTUAL): June 19, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 6, 2021
• Last Update Submitted That Met QC Criteria: January 4, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: stroke; COVID-19; neurocognitive; nervous system
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: MIRO_001_2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No