Video Games to Track Cognitive Health

Not Applicable

• Conditions: Dementia; Acute Changes in Cognition; Cognitive Impairment; Mild Traumatic Brain Injury; Mild Cognitive Impairment; Cognitive Decline; Acute Head Injury; Cognitive Changes; Concussion
• Interventions: Other: SLUMS; Other: MMSE; Other: MoCA; Device: BrainCheck

• Registration Number: NCT03608722
• Lead Sponsor: BrainCheck, Inc.

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).

Study Timeline

• Study Start: 2015-11
• Primary Completion: 2017-08
• Study First Submitted: 2018-05-22
• Study First Submitted QC: 2018-07-24
• Study First Posted: 2018-08-01
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-15
• Last Update Posted: 2019-07-16
• Study Completion: 2020-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BrainCheck vs Pen and paper tests	MMSE	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
BrainCheck vs Pen and paper tests	SLUMS	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
BrainCheck vs Pen and paper tests	BrainCheck	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
BrainCheck vs Pen and paper tests	MoCA	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
BrainCheck performance in ESRD patients	BrainCheck	Assess BrainCheck test performance in patients with ESRD and how undergoing hemodialysis treatment can impact cognitive performance.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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