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Integrated Eye Tracking and Neural Monitoring for Enhanced Assessment of Mild TBI: Primary Study

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ClinicalTrials.gov Identifier: NCT03777228
Recruitment Status : Completed
First Posted : December 17, 2018
Last Update Posted : December 17, 2018
Sponsor:
Information provided by (Responsible Party):
Uniformed Services University of the Health Sciences

Study Description
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Brief Summary:
This study was conducted to develop and validate integrated eye tracking and EEG measures for assessment of mild traumatic brain injury.

Condition or disease
Mild Traumatic Brain Injury

Study Design
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Study Type : Observational
Actual Enrollment : 64 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Integrated Eye Tracking and Neural Monitoring for Enhanced Assessment of Mild TBI: Primary Study
Actual Study Start Date : April 15, 2015
Actual Primary Completion Date : March 15, 2017
Actual Study Completion Date : March 15, 2017

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Control
Individuals without traumatic brain injury
Mild TBI
Individuals with mild traumatic brain injury
Moderate to Severe TBI
Individual with moderate to severe traumatic brain injury


Outcome Measures
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Primary Outcome Measures :
  1. Saccadic RT [ Time Frame: 1 day (single time point) ]
    Saccadic Response Time


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants will be recruited through USUHS, the Walter Reed National Military Medical Center, the National Intrepid Center of Excellence, Malcolm Grow Medical Center, the Washington DC VA Medical Center, VA outpatient treatment centers and Vet Centers in the greater Washington, D.C. area, Fort Belvoir, Fort Detrick and Fort Meade, public areas in the surrounding community, and in clinical settings such as such as concussion clinics, neurorehabilitation centers, and other local private practices.
Criteria

Inclusion Criteria:

  • age 18 -55, ability to use left and right hands and right foot to complete cognitive and motor tasks without adaptive equipment, and fluent in English

Exclusion Criteria:

  • history of severe TBI, history of neurological illness unrelated to TBI, vision problems that are uncorrected by contacts or glasses, history of psychotic disorder, or current homicidal or suicidal ideation or intent
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Uniformed Services University of the Health Sciences
ClinicalTrials.gov Identifier: NCT03777228    
Other Study ID Numbers: G172NU-S1
First Posted: December 17, 2018    Key Record Dates
Last Update Posted: December 17, 2018
Last Verified: June 2017
Keywords provided by Uniformed Services University of the Health Sciences:
Traumatic brain injury, concussion, eye tracking, EEG, fMRI, DTI, Neurocognition
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Head Injuries, Closed
Wounds, Nonpenetrating