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Clinical Trials/NCT03608722
NCT03608722UnknownNot Applicable

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

BrainCheck, Inc.0 sites2,500 target enrollmentStarted: November 1, 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
2,500
Primary Endpoint
Identification of cognitive function performance utilizing a BrainCheck score

Study Overview

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 Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
10 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts 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

Outcomes

Primary Outcomes

Identification of cognitive function performance utilizing a BrainCheck score

Time Frame: 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 Outcomes

  • 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)

Investigators

Sponsor
BrainCheck, Inc.
Sponsor Class
Other
Responsible Party
Sponsor

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