Clinical trial NCT04438967: Brain Health in the Time of COVID-19
Official title: Brain Health in the Time of COVID-19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Brain Health
Keywords: COVID-19
neurocognitive
stroke
nervous system
Lead sponsor: Miro Health
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
name: University of Pittsburgh
First posted: 2020-06-19
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population is open to anyone over the age of 18 who can consent for themself.

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/

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.

Eligibility criteria: 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

Primary outcomes:
measure: Test the hypothesis that COVID-19 infection will lead to increased risk of neurological impairment
timeFrame: ~1 year
measure: Determine cognitive and behavioral functional patterns that predict susceptibility to neurological impairment due to COVID-19
timeFrame: ~1 year
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Miro Health
state: California
Study officials:
affiliation: Miro Health
name: Natasha Belfor, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Leah Rubin, PhD
role: PRINCIPAL_INVESTIGATOR
References: