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Eye-Tracking Rapid Attention Computation (Eye-TRAC)

This study is currently recruiting participants.
Verified February 2012 by Brain Trauma Foundation
Sponsor:
Collaborator:
Department of Defense
Information provided by (Responsible Party):
Jamshid Ghajar, M.D., Ph.D., Brain Trauma Foundation
ClinicalTrials.gov Identifier:
NCT00743821
First received: August 28, 2008
Last updated: February 2, 2012
Last verified: February 2012
History of Changes
  Purpose

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
Post Concussive Syndrome, Chronic

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Eye-Tracking Rapid Attention Computation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Brain Trauma Foundation:

Estimated Enrollment: 150
Study Start Date: September 2008
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

TBI patients will be recruited from an outpatient TBI clinic Normals will be friends/family of TBI patients who have not suffered a TBI, as well as individuals recruited from the community

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00743821

Contacts
Contact: Alison Schonberger, BA 212-772-0608 ext 115 aschonberger@braintrauma.org

Locations
United States, New York
Citigroup Imaging Center, Weill Medical College of Cornell University Recruiting
New York, New York, United States, 10021
Principal Investigator: Jamshid Ghajar, M.D., Ph.D.            
Sponsors and Collaborators
Brain Trauma Foundation
Department of Defense
Investigators
Principal Investigator: Jamshid Ghajar, M.D., Ph.D. Brain Trauma Foundation
  More Information

No publications provided

Responsible Party: Jamshid Ghajar, M.D., Ph.D., President, Brain Trauma Foundation
ClinicalTrials.gov Identifier: NCT00743821     History of Changes
Other Study ID Numbers: PT075553, IRB Protocol #0211005884
Study First Received: August 28, 2008
Last Updated: February 2, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Post-Concussion Syndrome
Brain Concussion
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds and Injuries
Wounds, Nonpenetrating

ClinicalTrials.gov processed this record on June 17, 2013