Video Games to Track Cognitive Health

BrainCheck, Inc.

Status: Unknown

Conditions: Acute Changes in Cognition; Acute Head Injury; Cognitive Impairment; Concussion; Mild Cognitive Impairment; Cognitive Changes; Cognitive Decline; Mild Traumatic Brain Injury; Dementia

Treatments: Other: MoCA; Other: MMSE; Device: BrainCheck; Other: SLUMS

Study type: Interventional

Funder types: Other

Identifiers

NCT03608722

1MAY15-93

Details and patient eligibility

About

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.

Full 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).

Enrollment: 2,500 patients

Sex: All

Ages: 10+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,500 participants in 2 patient groups

BrainCheck vs Pen and paper tests

Experimental group

Description:

Compare patient performance on BrainCheck neurocognitive test vs pen and paper dementia tests (SLUMS, MMSE, MoCA), as well as an exploratory analysis comparing BrainCheck performance to aid in identifying patients with MCI and dementia vs physician diagnosis

Treatment:

Other: SLUMS

Other: MoCA

Other: MMSE

Device: BrainCheck

BrainCheck performance in ESRD patients

Experimental group

Description:

Assess BrainCheck test performance in patients with ESRD and how undergoing hemodialysis treatment can impact cognitive performance.

Treatment:

Device: BrainCheck