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Integrated Eye Tracking and Neural Monitoring for TBI: Optimization

N

Naval Medical Center

Status

Completed

Conditions

Traumatic Brain Injury

Study type

Observational

Funder types

Other U.S. Federal agency

Identifiers

NCT03451058
NMCSD.2017.0012

Details and patient eligibility

About

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.

Full 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.

Enrollment

138 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

138 participants in 3 patient groups

Mild TBI Group
Description:
History of head injury, Active Duty Service Member or Veteran, age 18-55, fluent in English
Moderate to Severe TBI Group
Description:
History of head injury, Active Duty Service Member or Veteran, age 18-55, fluent in English
Healthy Controls
Description:
No history of head injury, Active Duty Service Member or Veteran, age 18-55, fluent in English

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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