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Integrated Eye Tracking and Neural Monitoring for TBI: Optimization

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ClinicalTrials.gov Identifier: NCT03451058
Recruitment Status : Recruiting
First Posted : March 1, 2018
Last Update Posted : March 13, 2019
Sponsor:
Collaborators:
Uniformed Services University of the Health Sciences
The Defense and Veterans Brain Injury Center
Information provided by (Responsible Party):
Lynita Mullins, United States Naval Medical Center, San Diego

Brief Summary:
Traumatic brain injury (TBI) is one of the most frequent injuries affecting service members. Unfortunately, current neurocognitive assessment tools are unable to reliably detect mild TBI more than a few days post- injury. Therefore, development of advanced systems for assessment and diagnosis of TBI are a top priority within Department of Defense. This project aims to evaluate a combined electroencephalography (EEG) and eye tracking system capable of assessing compromised cognitive function stemming from TBI, with the goal of enhancing operational readiness and aiding in diagnosis, improving health care and rehabilitation for affected military personnel.

Condition or disease
Traumatic Brain Injury

Detailed Description:

This study (N=100) will be a correlational study to assess cognitive function in healthy controls, individuals with mild TBI, and individuals with moderate-to-severe TBI.

In general, participants will provide demographic information, medical history, and details of their head injury. Participants will also complete a brief neuropsychological assessment to obtain an index of cognitive ability, along with the Fusion Test with eye tracking and linked EEG. MRI data may also be obtained.


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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Integrated Eye Tracking and Neural Monitoring for Enhanced Assessment of Mild TBI: Clinical Optimization Study
Actual Study Start Date : July 7, 2017
Estimated Primary Completion Date : April 24, 2020
Estimated Study Completion Date : April 24, 2020

Resource links provided by the National Library of Medicine


Group/Cohort
Mild TBI Group
History of head injury, Active Duty Service Member or Veteran, age 18-55, fluent in English
Moderate to Severe TBI Group
History of head injury, Active Duty Service Member or Veteran, age 18-55, fluent in English
Healthy Controls
No history of head injury, Active Duty Service Member or Veteran, age 18-55, fluent in English



Primary Outcome Measures :
  1. EEG [ Time Frame: One study visit ]
    Spectral features and event related responses collected from scalp measurements during performance of an eye movement and working memory task.

  2. Eye Tracking [ Time Frame: One study visit ]
    Saccadic latencies measured in response to cognitive task including working memory demands.


Secondary Outcome Measures :
  1. Neurobehavioral Symptom Inventory (NSI) [ Time Frame: One study visit ]
    Self-report measure of post-concussive symptoms

  2. Trail Making Test [ Time Frame: One study visit ]
    Consists of Part A and B which depends on psychomotor speed, visual search abilities, and placing demands on working memory and cognitive flexibility

  3. Symbol Search [ Time Frame: One study visit ]
    Wechsler Adult Intelligence Scale- Fourth Edition (WAIS-IV) Symbol Search measures information processing speed

  4. Digit Span [ Time Frame: One study visit ]
    WAIS-IV Digit Span including Digit Span Forward, Digit Span Backward, and Digit Span Sequencing, which measures memory span.



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:   Probability Sample
Study Population
Male and female service members with or without traumatic brain injury (TBI).
Criteria

Inclusion Criteria:

All groups:

  • Ability to use dominant hand to complete cognitive and motor tasks
  • Fluent in English

Mild TBI group:

  • History of mild TBI > 3 months and < 10 years prior to enrollment
  • Self-report of post-concussive symptoms

Moderate-to-Severe TBI group:

- History of moderate or severe TBI > 3 months and < 10 years prior to enrollment

Exclusion Criteria:

Control group:

History of possible or confirmed brain injury

All groups:

  • History of a medical condition (other than brain injury) that would be expected to affect cognitive or motor abilities (e.g. muscular dystrophy, multiple sclerosis, or psychotic disorders such as schizophrenia)
  • Presence of neurological condition, such as brain tumor, brain infection, seizure, or stroke
  • Presence of visual impairment that is uncorrected by glasses or contacts (including color blindness)
  • Evidence of current suicidal or homicidal ideation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03451058


Contacts
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Contact: Mark Ettenhofer, Ph.D. 301-259-1403 FUSION@USUHS.EDU

Locations
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United States, California
Naval Medical Center San Diego Recruiting
San Diego, California, United States, 92134
Contact: Mark Ettenhofer, Ph.D.    301-259-1403    FUSION@USUHS.EDU   
Sponsors and Collaborators
United States Naval Medical Center, San Diego
Uniformed Services University of the Health Sciences
The Defense and Veterans Brain Injury Center

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Responsible Party: Lynita Mullins, Department Head, Physical Medicine and Rehabilitation, United States Naval Medical Center, San Diego
ClinicalTrials.gov Identifier: NCT03451058     History of Changes
Other Study ID Numbers: NMCSD.2017.0012
First Posted: March 1, 2018    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lynita Mullins, United States Naval Medical Center, San Diego:
Traumatic brain injury, eye tracking, EEG, cognition

Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries