Video Games to Track Cognitive Health

NCT ID: NCT03608722

Last Updated: 2019-07-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 2500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2020-05-31

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).

Conditions

Dementia; Mild Cognitive Impairment; Cognitive Impairment; Cognitive Decline; Cognitive Changes; Acute Changes in Cognition; Acute Head Injury; Concussion; Mild Traumatic Brain Injury

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

BrainCheck vs Pen and paper tests

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

Group Type: EXPERIMENTAL

SLUMS

Intervention Type: OTHER

A pen and paper screening tool of cognitive impairment

MMSE

Intervention Type: OTHER

A pen and paper screening tool of cognitive impairment

MoCA

Intervention Type: OTHER

A pen and paper screening tool for cognitive impairment

BrainCheck

Intervention Type: DEVICE

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

BrainCheck performance in ESRD patients

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

Group Type: EXPERIMENTAL

BrainCheck

Intervention Type: DEVICE

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

Interventions

SLUMS

A pen and paper screening tool of cognitive impairment

Intervention Type: OTHER

MMSE

A pen and paper screening tool of cognitive impairment

Intervention Type: OTHER

MoCA

A pen and paper screening tool for cognitive impairment

Intervention Type: OTHER

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

Intervention Type: DEVICE

Other Intervention Names

St. Louis University Mental Status Exam; The Mini-Mental State Examination or Folstein test; Montreal Cognitive assessment

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

• Minimum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

BrainCheck, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: DERIVED

PMID: 31518280 (View on PubMed)

Other Identifiers

1MAY15-93

Identifier Type: -

Identifier Source: org_study_id