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Eye-TRAC: Eye-Tracking Rapid Attention Computation

Sponsor
Brain Trauma Foundation (Other)
Overall Status
Completed
CT.gov ID
NCT00743821
Collaborator
United States Department of Defense (U.S. Fed)
426
Enrollment
1
Location
47
Duration (Months)
9.1
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

    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 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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    426 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Eye-Tracking Rapid Attention Computation
    Study Start Date :
    Oct 1, 2008
    Actual Primary Completion Date :
    Sep 1, 2012
    Actual Study Completion Date :
    Sep 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    TBI Patients

    Individuals who have suffered a mild traumatic brain injury and have persistent post-concussive symptoms (PCS)
    Normals

    Individuals of comparable age and education who have not suffered a traumatic brain injury

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years to 55 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      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

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Citigroup Imaging Center, Weill Medical College of Cornell University New York New York United States 10021

      Sponsors and Collaborators

      • Brain Trauma Foundation
      • United States Department of Defense

      Investigators

      • Principal Investigator: Jamshid Ghajar, M.D., Ph.D., Brain Trauma Foundation

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Jamshid Ghajar, M.D., Ph.D., President, Brain Trauma Foundation
      ClinicalTrials.gov Identifier:
      NCT00743821
      Other Study ID Numbers:
      • PT075553
      • IRB Protocol #0211005884
      First Posted:
      Aug 29, 2008
      Last Update Posted:
      May 7, 2014
      Last Verified:
      May 1, 2014
      Additional relevant MeSH terms:
      Post-Concussion Syndrome

      Study Results

      No Results Posted as of May 7, 2014