Integrated Eye Tracking and Neural Monitoring for TBI: Optimization

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

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.

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 138

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92134
      • Naval Medical Center San Diego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Male and female service members with or without traumatic brain injury (TBI).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EEG	Spectral features and event related responses collected from scalp measurements during performance of an eye movement and working memory task.	One study visit
Eye Tracking	Saccadic latencies measured in response to cognitive task including working memory demands.	One study visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurobehavioral Symptom Inventory (NSI)	Self-report measure of post-concussive symptoms	One study visit
Trail Making Test	Consists of Part A and B which depends on psychomotor speed, visual search abilities, and placing demands on working memory and cognitive flexibility	One study visit
Symbol Search	Wechsler Adult Intelligence Scale- Fourth Edition (WAIS-IV) Symbol Search measures information processing speed	One study visit
Digit Span	WAIS-IV Digit Span including Digit Span Forward, Digit Span Backward, and Digit Span Sequencing, which measures memory span.	One study visit

Collaborators and Investigators

• Sponsor: United States Naval Medical Center, San Diego
• Collaborators: Uniformed Services University of the Health Sciences; The Defense and Veterans Brain Injury Center

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2017
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: October 3, 2017
• First Submitted That Met QC Criteria: February 23, 2018
• First Posted (Actual): March 1, 2018

Study Record Updates

• Last Update Posted (Actual): February 11, 2022
• Last Update Submitted That Met QC Criteria: February 9, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Traumatic brain injury, eye tracking, EEG, cognition
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: NMCSD.2017.0012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No