Eye-Tracking Rapid Attention Computation (Eye-TRAC)
|ClinicalTrials.gov Identifier: NCT00743821|
Recruitment Status : Completed
First Posted : August 29, 2008
Last Update Posted : May 7, 2014
|Condition or disease|
|Post Concussive Syndrome, Chronic|
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 subject's 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:
- 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.
- 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.
1.1. Test reliability by examining the test-retest reliability measures of EYE-TRAC;
1.2. Test selectivity by testing the ability to differentiating the effects of fatigue, aging, and mTBI on EYE-TRAC measures;
1.3. 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;
1.4. Test specificity by measuring the spectrum of TBI injury using MRI-DTI and correlate with EYE-TRAC.
|Study Type :||Observational|
|Actual Enrollment :||426 participants|
|Observational Model:||Case Control|
|Official Title:||Eye-Tracking Rapid Attention Computation|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||September 2012|
Individuals who have suffered a mild traumatic brain injury and have persistent post-concussive symptoms (PCS)
Individuals of comparable age and education who have not suffered a traumatic brain injury
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00743821
|United States, New York|
|Citigroup Imaging Center, Weill Medical College of Cornell University|
|New York, New York, United States, 10021|
|Principal Investigator:||Jamshid Ghajar, M.D., Ph.D.||Brain Trauma Foundation|