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Video Games to Track Cognitive Health

Primary Purpose

Dementia, Mild Cognitive Impairment, Cognitive Impairment

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SLUMS
MMSE
MoCA
BrainCheck
Sponsored by
BrainCheck, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Dementia

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)All SexesAccepts 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    BrainCheck vs Pen and paper tests

    BrainCheck performance in ESRD patients

    Arm 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

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

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    May 22, 2018
    Last Updated
    July 15, 2019
    Sponsor
    BrainCheck, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03608722
    Brief Title
    Video Games to Track Cognitive Health
    Official Title
    BrainCheck: Using Simple Video Games to Detect and Track Cognitive Health and Impairment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2015 (Actual)
    Primary Completion Date
    August 2017 (Actual)
    Study Completion Date
    May 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    BrainCheck, Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dementia, Mild Cognitive Impairment, Cognitive Impairment, Cognitive Decline, Cognitive Changes, Acute Changes in Cognition, Acute Head Injury, Concussion, Mild Traumatic Brain Injury

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    2500 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    BrainCheck vs Pen and paper tests
    Arm Type
    Experimental
    Arm 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
    Arm Title
    BrainCheck performance in ESRD patients
    Arm Type
    Experimental
    Arm Description
    Assess BrainCheck test performance in patients with ESRD and how undergoing hemodialysis treatment can impact cognitive performance.
    Intervention Type
    Other
    Intervention Name(s)
    SLUMS
    Other Intervention Name(s)
    St. Louis University Mental Status Exam
    Intervention Description
    A pen and paper screening tool of cognitive impairment
    Intervention Type
    Other
    Intervention Name(s)
    MMSE
    Other Intervention Name(s)
    The Mini-Mental State Examination or Folstein test
    Intervention Description
    A pen and paper screening tool of cognitive impairment
    Intervention Type
    Other
    Intervention Name(s)
    MoCA
    Other Intervention Name(s)
    Montreal Cognitive assessment
    Intervention Description
    A pen and paper screening tool for cognitive impairment
    Intervention Type
    Device
    Intervention Name(s)
    BrainCheck
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Identification of cognitive function performance utilizing a BrainCheck score
    Description
    Utilizing BrainCheck to assess the ability of an individual to perform various mental activities on a score ranging from 0 to 30
    Time Frame
    Throughout study completion, expected to be 3 years
    Secondary Outcome Measure Information:
    Title
    Identification of cognitive function performance on BrainCheck compared to pen and paper tests
    Description
    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
    Time Frame
    Expect 2 years for subject enrollment. Data analysis to be completed 6 months after last subject enrolled

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    31518280
    Citation
    Groppell S, Soto-Ruiz KM, Flores B, Dawkins W, Smith I, Eagleman DM, Katz Y. A Rapid, Mobile Neurocognitive Screening Test to Aid in Identifying Cognitive Impairment and Dementia (BrainCheck): Cohort Study. JMIR Aging. 2019 Mar 21;2(1):e12615. doi: 10.2196/12615.
    Results Reference
    derived

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    Video Games to Track Cognitive Health

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