Integrated Eye Tracking and Neural Monitoring for TBI: Optimization

NCT ID: NCT03451058

Last Updated: 2022-02-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 138 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-07-07
• Study Completion Date: 2021-12-31

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.

Conditions

Traumatic Brain Injury

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Mild TBI Group

History of head injury, Active Duty Service Member or Veteran, age 18-55, fluent in English

No interventions assigned to this group

Moderate to Severe TBI Group

History of head injury, Active Duty Service Member or Veteran, age 18-55, fluent in English

No interventions assigned to this group

Healthy Controls

No history of head injury, Active Duty Service Member or Veteran, age 18-55, fluent in English

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Uniformed Services University of the Health Sciences

FED

Sponsor Role: collaborator

The Defense and Veterans Brain Injury Center

FED

Sponsor Role: collaborator

United States Naval Medical Center, San Diego

FED

Sponsor Role: lead

Responsible Party

Lynita Mullins

Department Head, Physical Medicine and Rehabilitation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Naval Medical Center San Diego

San Diego, California, United States

Countries

United States

Other Identifiers

NMCSD.2017.0012

Identifier Type: -

Identifier Source: org_study_id