Video Games to Track Cognitive Health

Dementia Clinical Trial

Official title:

BrainCheck: Using Simple Video Games to Detect and Track Cognitive Health and Impairment

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03608722
• Other study ID #: 1MAY15-93
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2015
• Est. completion date: May 2020

Study information

• Verified date: July 2019
• Source: BrainCheck, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2500
• Est. completion date: May 2020
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Changes in Cognition
• Acute Head Injury
• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Cognitive Changes
• Cognitive Decline
• Cognitive Dysfunction
• Cognitive Impairment
• Concussion
• Craniocerebral Trauma
• Dementia
• Mild Cognitive Impairment
• Mild Traumatic Brain Injury
• Wounds and Injuries

Intervention

Other:
• SLUMS
A pen and paper screening tool of cognitive impairment
• MMSE
A pen and paper screening tool of cognitive impairment
• MoCA
A pen and paper screening tool for cognitive impairment

Device:
• BrainCheck
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
BrainCheck, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of cognitive function performance utilizing a BrainCheck score	Utilizing BrainCheck to assess the ability of an individual to perform various mental activities on a score ranging from 0 to 30	Throughout study completion, expected to be 3 years
Secondary	Identification of cognitive function performance on BrainCheck compared to pen and paper tests	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	Expect 2 years for subject enrollment. Data analysis to be completed 6 months after last subject enrolled