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Integrated Eye Tracking and Neural Monitoring for TBI: Optimization

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03451058
Enrollment
138
Registered
2018-03-01
Start date
2017-07-07
Completion date
2021-12-31
Last updated
2022-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury

Keywords

Traumatic brain injury, eye tracking, EEG, cognition

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.

Interventions

None listed

Sponsors

Uniformed Services University of the Health Sciences
CollaboratorFED
The Defense and Veterans Brain Injury Center
CollaboratorFED
United States Naval Medical Center, San Diego
Lead SponsorFED

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
EEGOne study visitSpectral features and event related responses collected from scalp measurements during performance of an eye movement and working memory task.
Eye TrackingOne study visitSaccadic latencies measured in response to cognitive task including working memory demands.

Secondary

MeasureTime frameDescription
Neurobehavioral Symptom Inventory (NSI)One study visitSelf-report measure of post-concussive symptoms
Trail Making TestOne study visitConsists of Part A and B which depends on psychomotor speed, visual search abilities, and placing demands on working memory and cognitive flexibility
Symbol SearchOne study visitWechsler Adult Intelligence Scale- Fourth Edition (WAIS-IV) Symbol Search measures information processing speed
Digit SpanOne study visitWAIS-IV Digit Span including Digit Span Forward, Digit Span Backward, and Digit Span Sequencing, which measures memory span.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026