NCT03608722

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2015

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 1, 2018

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

July 16, 2019

Status Verified

July 1, 2019

Enrollment Period

1.8 years

First QC Date

May 22, 2018

Last Update Submit

July 15, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    Throughout study completion, expected to be 3 years

Secondary Outcomes (1)

  • 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

Study Arms (2)

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

Other: SLUMSOther: MMSEOther: MoCADevice: BrainCheck

BrainCheck performance in ESRD patients

EXPERIMENTAL

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

Device: BrainCheck

Interventions

SLUMSOTHER

A pen and paper screening tool of cognitive impairment

Also known as: St. Louis University Mental Status Exam
BrainCheck vs Pen and paper tests
MMSEOTHER

A pen and paper screening tool of cognitive impairment

Also known as: The Mini-Mental State Examination or Folstein test
BrainCheck vs Pen and paper tests
MoCAOTHER

A pen and paper screening tool for cognitive impairment

Also known as: Montreal Cognitive assessment
BrainCheck vs Pen and paper tests

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 patientsBrainCheck vs Pen and paper tests

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 10 or older
  • Function of both hands

You may not qualify if:

  • Inability to speak English or Spanish
  • Inability to read English or Spanish
  • Unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

DementiaCognitive DysfunctionBrain Concussion

Interventions

Poverty AreasMental Status and Dementia Tests

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersCognition DisordersBrain Injuries, TraumaticBrain InjuriesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

PovertySocioeconomic FactorsPopulation CharacteristicsNeuropsychological TestsPsychological TestsBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2018

First Posted

August 1, 2018

Study Start

November 1, 2015

Primary Completion

August 1, 2017

Study Completion

May 1, 2020

Last Updated

July 16, 2019

Record last verified: 2019-07