Ignite Creation Date:
2024-05-05 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 9:54 AM
Study NCT ID:
NCT00743821
Status:
COMPLETED
Last Update Posted:
2014-05-07
First Post:
2008-08-28
Brief Title:
Eye-Tracking Rapid Attention Computation
Sponsor:
Brain Trauma Foundation
Organization:
Brain Trauma Foundation
Study Overview
Official Title:
Eye-Tracking Rapid Attention Computation
Status:
COMPLETED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Eye-TRAC
Brief Summary:
The purpose of this study is to validate and refine a diagnostic device that can detect attention and memory deficits that result from mild traumatic brain injury mTBI
Detailed Description:
The main goal of this project is the development of a military-ready sensitive and rapid eye tracking diagnostic device for individuals with mild traumatic brain injury mTBI The device will also be tested for its efficacy in diagnosing fatigue and identifying aging effects We will use a predictive visual tracking paradigm to dynamically capture the attentional state and correlate the subjects performance with the degree of disruption in the attention network caused by mTBI aging and fatigue The device will be tested for its diagnostic capabilities based on its selectivity reliability sensitivity and validity for individuals of varying ages with and without mTBI and in military personnel who have undergone 26 hours of sleep deprivation
Testing will be conducted at two sites
1 Civilians with mTBI and civilians with adult attention deficit hyperactivity disorder will be tested by trained staff of the Brain Trauma Foundation BTF at Weill Cornell Medical College WCMC in New York City The ages of the enrolled individuals will range between 18-55 years in order to examine aging effects
2 Enrolled service members will be tested at the United States Army Research Institute of Environmental Medicine USARIEM in Natick Massachusetts These service members will be healthy volunteers without a history of mTBI Some of these subjects will undergo 26 hours of sleep deprivation during which they will be tested at specific time points
Our objectives are
1 Prove that the eye-tracking concept can be brought from a successful laboratory device to a specific reliable selective and valid diagnostic tool
11 Test reliability by examining the test-retest reliability measures of EYE-TRAC
12 Test selectivity by testing the ability to differentiating the effects of fatigue aging and mTBI on EYE-TRAC measures
13 Test validity by determining the relationship between measures of attention and working memory based on the EYE-TRAC and validated measures of sustained attention and working memory
14 Test specificity by measuring the spectrum of TBI injury using MRI-DTI and correlate with EYE-TRAC
Testing will be conducted at two sites
1 Civilians with mTBI and civilians with adult attention deficit hyperactivity disorder will be tested by trained staff of the Brain Trauma Foundation BTF at Weill Cornell Medical College WCMC in New York City The ages of the enrolled individuals will range between 18-55 years in order to examine aging effects
2 Enrolled service members will be tested at the United States Army Research Institute of Environmental Medicine USARIEM in Natick Massachusetts These service members will be healthy volunteers without a history of mTBI Some of these subjects will undergo 26 hours of sleep deprivation during which they will be tested at specific time points
Our objectives are
1 Prove that the eye-tracking concept can be brought from a successful laboratory device to a specific reliable selective and valid diagnostic tool
11 Test reliability by examining the test-retest reliability measures of EYE-TRAC
12 Test selectivity by testing the ability to differentiating the effects of fatigue aging and mTBI on EYE-TRAC measures
13 Test validity by determining the relationship between measures of attention and working memory based on the EYE-TRAC and validated measures of sustained attention and working memory
14 Test specificity by measuring the spectrum of TBI injury using MRI-DTI and correlate with EYE-TRAC
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IRB Protocol 0211005884 | None | None | None |