Integrated Eye Tracking and Neural Monitoring for TBI: Optimization

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03451058
• Other study ID #: NMCSD.2017.0012
• Status: Completed
• Start date: July 7, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2022
• Source: United States Naval Medical Center, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury

Locations

Country	Name	City	State
United States	Naval Medical Center San Diego	San Diego	California

Sponsors (3)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EEG	Spectral features and event related responses collected from scalp measurements during performance of an eye movement and working memory task.	One study visit
Primary	Eye Tracking	Saccadic latencies measured in response to cognitive task including working memory demands.	One study visit
Secondary	Neurobehavioral Symptom Inventory (NSI)	Self-report measure of post-concussive symptoms	One study visit
Secondary	Trail Making Test	Consists of Part A and B which depends on psychomotor speed, visual search abilities, and placing demands on working memory and cognitive flexibility	One study visit
Secondary	Symbol Search	Wechsler Adult Intelligence Scale- Fourth Edition (WAIS-IV) Symbol Search measures information processing speed	One study visit
Secondary	Digit Span	WAIS-IV Digit Span including Digit Span Forward, Digit Span Backward, and Digit Span Sequencing, which measures memory span.	One study visit