Eye-Tracking Rapid Attention Computation

Post Concussive Syndrome, Chronic Clinical Trial

— Eye-TRAC  

Official title:

Eye-Tracking Rapid Attention Computation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00743821
• Other study ID #: PT075553
• Secondary ID: IRB Protocol #02
• Status: Completed
• Phase: N/A
• First received: August 28, 2008
• Last updated: May 5, 2014
• Start date: October 2008
• Est. completion date: September 2012

Study information

• Verified date: May 2014
• Source: Brain Trauma Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

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 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:

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 426
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Normals:

Inclusion Criteria:

• Healthy volunteer

• Education up to 12th grade

Exclusion Criteria:

• History of concussion or TBI

• Alcohol or substance abuse problems, neurological disorders, major psychiatric disorders (including ADHD or PTSD)

• Gross visual or hearing problems

• Pregnancy

• Metal in the body or any contraindications for MRI

TBI Patients:

Inclusion Criteria:

• Education up to 12th grade

• Persistent post concussive symptoms after an isolated incident of head injury with or without loss of consciousness between 3 months to 5 years prior to participation

Exclusion Criteria

• Prior history of seizures

• Pregnant woman

• Alcohol or substance abuse problems, neurological disorders, major psychiatric disorders (including ADHD or PTSD)

• Gross visual or hearing problems

• Any metal in the body or contraindications for MRI

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Post Concussive Syndrome, Chronic
• Post-Concussion Syndrome

Locations

Country	Name	City	State
United States	Citigroup Imaging Center, Weill Medical College of Cornell University	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Brain Trauma Foundation	United States Department of Defense

Country where clinical trial is conducted

United States,