Dementia, Mild Cognitive Impairment, Cognitive Impairment, Cognitive Decline, Cognitive Changes, Acute Changes in Cognition, Acute Head Injury, Concussion, Mild Traumatic Brain Injury
Conditions
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).
Interventions
OTHERSLUMS
A pen and paper screening tool of cognitive impairment
OTHERMMSE
A pen and paper screening tool of cognitive impairment
OTHERMoCA
A pen and paper screening tool for cognitive impairment
DEVICEBrainCheck
A computerized neurocognitive test administered via an electronic device, such as a phone, tablet or computer, that contains several assessments that will aid in establishing an individuals cognitive performance
Sponsors
BrainCheck, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Identification of cognitive function performance utilizing a BrainCheck score | Throughout study completion, expected to be 3 years | Utilizing BrainCheck to assess the ability of an individual to perform various mental activities on a score ranging from 0 to 30 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Identification of cognitive function performance on BrainCheck compared to pen and paper tests | Expect 2 years for subject enrollment. Data analysis to be completed 6 months after last subject enrolled | Comparing BrainCheck's performance vs pen and paper dementia tests to establish sensitivity and specificity of BrainCheck to help identify patients with MCI and dementia |
Outcome results
None listed