Brain Health in the Time of COVID-19

Sponsor

Miro Health (Other)

Overall Status

Recruiting

CT.gov ID

NCT04438967

Collaborator

Johns Hopkins University (Other), University of Pittsburgh (Other)

10,000

Enrollment

Location

18.5

Anticipated Duration (Months)

540.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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/

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational

Anticipated Enrollment :

10000 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

Brain Health in the Time of COVID-19

Actual Study Start Date :

Jun 16, 2020

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Miro Health	San Francisco	California	United States	94107

Sponsors and Collaborators

Miro Health
Johns Hopkins University
University of Pittsburgh

Investigators

Principal Investigator: Natasha Belfor, PhD, Miro Health
Principal Investigator: Leah Rubin, PhD, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

Responsible Party:

Miro Health

ClinicalTrials.gov Identifier:

NCT04438967

Other Study ID Numbers:

MIRO_001_2020

First Posted:

Jun 19, 2020

Last Update Posted:

Jan 6, 2021

Last Verified:

Jan 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Miro Health

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Jan 6, 2021