Integrated Eye Tracking and Neural Monitoring for TBI: Optimization

Completed

• Conditions: Traumatic Brain Injury

• Registration Number: NCT03451058
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2017-07-07
• Study First Submitted: 2017-10-03
• Study First Submitted QC: 2018-02-23
• Study First Posted: 2018-03-01
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-09
• Last Update Posted: 2022-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Symbol Search	One study visit	Wechsler Adult Intelligence Scale- Fourth Edition (WAIS-IV) Symbol Search measures information processing speed
Trail Making Test	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
Neurobehavioral Symptom Inventory (NSI)	One study visit	Self-report measure of post-concussive symptoms
Digit Span	One study visit	WAIS-IV Digit Span including Digit Span Forward, Digit Span Backward, and Digit Span Sequencing, which measures memory span.

Trial Locations

Locations (1)

Naval Medical Center San Diego; 🇺🇸 San Diego, California, United States