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临床试验/NCT03608722
NCT03608722Unknown不适用

BrainCheck: Using Simple Video Games to Detect and Track Cognitive Health and Impairment

BrainCheck, Inc.0 个研究点目标入组 2,500 人开始时间: 2015年11月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
2,500
主要终点
Identification of cognitive function performance utilizing a BrainCheck score

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
10 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 10 or older
  • Function of both hands

排除标准

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

结局指标

主要结局

Identification of cognitive function performance utilizing a BrainCheck score

时间窗: 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

次要结局

  • 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)

研究者

发起方
BrainCheck, Inc.
申办方类型
Other
责任方
Sponsor

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