Integrated Eye Tracking and Neural Monitoring for TBI: Optimization

• ClinicalTrials.gov Identifier: NCT03451058
• Recruitment Status: Completed
• First Posted: March 1, 2018
• Last Update Posted: February 11, 2022
• Sponsor: United States Naval Medical Center, San Diego
• Collaborators: Uniformed Services University of the Health Sciences; The Defense and Veterans Brain Injury Center
• Information provided by (Responsible Party): Lynita Mullins, United States Naval Medical Center, San Diego

Study Description

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.

Condition or disease
Traumatic Brain Injury

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 Design

• Study Type: Observational
• Actual Enrollment: 138 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Integrated Eye Tracking and Neural Monitoring for Enhanced Assessment of Mild TBI: Clinical Optimization Study
• Actual Study Start Date: July 7, 2017
• Actual Primary Completion Date: December 31, 2021
• Actual Study Completion Date: December 31, 2021

Groups and Cohorts

Group/Cohort
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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Probability Sample

Study Population

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

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

Contacts and Locations

Locations

United States, California

Naval Medical Center San Diego

San Diego, California, United States, 92134

Sponsors and Collaborators

United States Naval Medical Center, San Diego

Uniformed Services University of the Health Sciences

The Defense and Veterans Brain Injury Center

More Information

• Responsible Party: Lynita Mullins, Department Head, Physical Medicine and Rehabilitation, United States Naval Medical Center, San Diego
• ClinicalTrials.gov Identifier: NCT03451058
• Other Study ID Numbers: NMCSD.2017.0012
• First Posted: March 1, 2018
• Last Update Posted: February 11, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lynita Mullins, United States Naval Medical Center, San Diego:

Traumatic brain injury, eye tracking, EEG, cognition

Additional relevant MeSH terms:

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