Integrated Eye Tracking and Neural Monitoring for TBI: Optimization

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Traumatic Brain Injury

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mild TBI Group<br>History of head injury, Active Duty Service Member or Veteran, age 18-55, fluent in English | |
| Moderate to Severe TBI Group<br>History of head injury, Active Duty Service Member or Veteran, age 18-55, fluent in English | |
| Healthy Controls<br>No history of head injury, Active Duty Service Member or Veteran, age 18-55, fluent in English | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Traumatic brain injury, eye tracking, EEG, cognition