Clinical trial NCT03451058: Integrated Eye Tracking and Neural Monitoring for TBI: Optimization
Official title: Integrated Eye Tracking and Neural Monitoring for Enhanced Assessment of Mild TBI: Clinical Optimization Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Brain Injury
Keywords: Traumatic brain injury, eye tracking, EEG, cognition
Lead sponsor: United States Naval Medical Center, San Diego
Sponsor class: FED
Collaborators: name: Uniformed Services University of the Health Sciences
name: The Defense and Veterans Brain Injury Center
First posted: 2018-03-01
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Male and female service members with or without traumatic brain injury (TBI).

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.

Eligibility criteria: 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

Primary outcomes:
measure: EEG
timeFrame: One study visit
measure: Eye Tracking
timeFrame: One study visit
Secondary outcomes:
measure: Neurobehavioral Symptom Inventory (NSI)
timeFrame: One study visit
measure: Trail Making Test
timeFrame: One study visit
measure: Symbol Search
timeFrame: One study visit
measure: Digit Span
timeFrame: One study visit
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Naval Medical Center San Diego
state: California
Study officials:
References: