Integrated Eye Tracking and Neural Monitoring for TBI: Optimization

NCT03451058 | Completed

• 1 other identifier: NMCSD.2017.0012
• Study Type: observational
• Target: 138
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury

Keywords

Traumatic brain injury, eye tracking, EEG, cognition

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Neurobehavioral Symptom Inventory (NSI)

  One study visit

• Trail Making Test

  One study visit

• Symbol Search

  One study visit

• Digit Span

  One study visit

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Naval Medical Center San Diego

San Diego, California, 92134, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department Head, Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: October 3, 2017
• First Posted: March 1, 2018
• Study Start: July 7, 2017
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: February 11, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)