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Completed

NCT Number: NCT03451058

Integrated Eye Tracking and Neural Monitoring for TBI: Optimization

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Naval Medical Center San Diego

San Diego, California, 92134, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

United States Naval Medical Center, San Diego

Fed

Collaborators

  • The Defense and Veterans Brain Injury Center
  • Uniformed Services University of the Health Sciences

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Mar 1, 2018
Registry last updated
Feb 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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