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
About this trial
This is an interventional diagnostic trial for Dementia
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
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
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
Learn more about this trial
Video Games to Track Cognitive Health
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