Clinical trial NCT03608722: Video Games to Track Cognitive Health
Official title: BrainCheck: Using Simple Video Games to Detect and Track Cognitive Health and Impairment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dementia
Mild Cognitive Impairment
Cognitive Impairment
Cognitive Decline
Cognitive Changes
Acute Changes in Cognition
Acute Head Injury
Concussion
Mild Traumatic Brain Injury
Lead sponsor: BrainCheck, Inc.
Sponsor class: OTHER
First posted: 2018-08-01
Enrollment: 2500
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to assess cognitive function using a rapid, portable, computerized neurocognitive testing device in a wide variety of clinical settings.

Detailed description: Investigators will recruit participants from public places using the convenience sampling method. Informed consent will be obtain from all participants/parents as well as assent from minors. Participants will be asked to complete a brief yes/no questionnaire before the study begins. Participants will be asked to complete a 10 minute battery of tests consisting of simple video games designed to measure cognitive health. No personally identifiable information will be collected during the tests and all test data will remain anonymous. Data will be stored on servers with HIPAA-level security. No participants will be asked to modify their normal behavior in any way. No feedback or results will be given to participants. The tests will not be distressing in any way. To meet the objective of detecting cognitive impairment, investigators will test a broad array of participants from ages 10 through 99 in several different settings in parallel. The targeted cognitive stressors of advanced age, head injuries, physical strain, sleep deprivation, alcohol ingestion, and marijuana ingestion will be compared to healthy baseline controls. Collectively, these experiments aim to yield an end- deliverable of a rapid, non-invasive, portable piece of software that can be used to detect cognitive impairment.

A subset of participants will be asked to take the tests up to three times, so the total testing time is a max of 30 minutes. A subset of participants will be asked simple auxiliary questions, such as "Estimated in minutes, how long was your exercise or workout?". A subset of participants will be asked to wear a FitBit device to monitor their heart rate. A subset of participants will be asked to take a breathalyzer test (BACtrack S80).

Eligibility criteria: Inclusion Criteria:

* Aged 10 or older
* Function of both hands

Exclusion Criteria:

* Inability to speak English or Spanish
* Inability to read English or Spanish
* Unable to provide informed consent

Primary outcomes:
measure: Identification of cognitive function performance utilizing a BrainCheck score
timeFrame: Throughout study completion, expected to be 3 years
Secondary outcomes:
measure: Identification of cognitive function performance on BrainCheck compared to pen and paper tests
timeFrame: Expect 2 years for subject enrollment. Data analysis to be completed 6 months after last subject enrolled
Other outcomes:
Locations:
Study officials:
References:
citation: Groppell S, Soto-Ruiz KM, Flores B, Dawkins W, Smith I, Eagleman DM, Katz Y. A Rapid, Mobile Neurocognitive Screening Test to Aid in Identifying Cognitive Impairment and Dementia (BrainCheck): Cohort Study. JMIR Aging. 2019 Mar 21;2(1):e12615. doi: 10.2196/12615.