DementiaNCT03608722
Video Games to Track Cognitive Health
A study testing SLUMS, MMSE and MoCA in people with Dementia and Mild Cognitive Impairment, run by BrainCheck, Inc..
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. Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Mild Cognitive Impairment, Cognitive Impairment
- What is being tested?
- SLUMS, MMSE and MoCA
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,500 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Aged 10 or older
- Function of both hands
Who cannot join
- Inability to speak English or Spanish
- Inability to read English or Spanish
- Unable to provide informed consent
About this study
Official title: BrainCheck: Using Simple Video Games to Detect and Track Cognitive Health and Impairment
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.
Read the 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
- Being tested
- SLUMS, MMSE, MoCA, BrainCheck
- Medical subject headings
- Dementia, Cognitive Dysfunction, Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLUMSOther
Also called St. Louis University Mental Status Exam
A pen and paper screening tool of cognitive impairment
MMSEOther
Also called The Mini-Mental State Examination or Folstein test
A pen and paper screening tool of cognitive impairment
MoCAOther
Also called Montreal Cognitive assessment
A pen and paper screening tool for cognitive impairment
BrainCheckDevice
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
| Study group | Role | What they receive |
|---|---|---|
| BrainCheck vs Pen and paper tests | Experimental | 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 Receives: Other: SLUMS; Other: MMSE; Other: MoCA; Device: BrainCheck |
| BrainCheck performance in ESRD patients | Experimental | Assess BrainCheck test performance in patients with ESRD and how undergoing hemodialysis treatment can impact cognitive performance. Receives: Device: BrainCheck |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Throughout study completion, expected to be 3 years
Secondary outcomes (1)
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
Measured: Expect 2 years for subject enrollment. Data analysis to be completed 6 months after last subject enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study startNov 2015
- Primary completionAug 2017
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- BrainCheck, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03608722
- Sponsor's protocol ID
- 1MAY15-93
- Status last verified
- Jul 2019
- First submitted
- 22 May 2018
- Last updated
- 16 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31518280
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BrainCheck: Using Simple Video Games to Detect and Track Cognitive Health and Impairment
- ClinicalTrials.gov ID
- NCT03608722
- Acronym / sponsor ID
- 1MAY15-93
- Conditions
- Dementia, Mild Cognitive Impairment, Cognitive Impairment, Cognitive Decline, Cognitive Changes, Acute Changes in Cognition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (actual)
- Lead sponsor
- BrainCheck, Inc.University, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- May 2020 (estimated)
- First posted
- 1 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BrainCheck vs Pen and paper tests | Experimental | Other: SLUMS, Other: MMSE, Other: MoCA, Device: BrainCheckCompare 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 |
| BrainCheck performance in ESRD patients | Experimental | Device: BrainCheckAssess BrainCheck test performance in patients with ESRD and how undergoing hemodialysis treatment can impact cognitive performance. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Aged 10 or older
- Function of both hands
Key exclusion criteria (3 listed)
- Inability to speak English or Spanish
- Inability to read English or Spanish
- Unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SLUMSAlso: St. Louis University Mental Status ExamA pen and paper screening tool of cognitive impairment | Other | BrainCheck vs Pen and paper tests |
| MMSEAlso: The Mini-Mental State Examination or Folstein testA pen and paper screening tool of cognitive impairment | Other | BrainCheck vs Pen and paper tests |
| MoCAAlso: Montreal Cognitive assessmentA pen and paper screening tool for cognitive impairment | Other | BrainCheck vs Pen and paper tests |
| BrainCheckA 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 | Device | BrainCheck performance in ESRD patients, BrainCheck vs Pen and paper tests |
Primary outcome
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
1 secondary outcome
Identification of cognitive function performance on BrainCheck compared to pen and paper tests
Time frame: Expect 2 years for subject enrollment. Data analysis to be completed 6 months after last subject enrolled
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
- Derived from this study: PubMed 31518280Groppell 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing SLUMS, MMSE and MoCA in people with Dementia and Mild Cognitive Impairment, run by BrainCheck, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of cognitive function performance utilizing a BrainCheck score (time frame: Throughout study completion, expected to be 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03608722, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2019; AzTrials last refreshed its copy on 1 Nov 2026.