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

NCT03777228 | Completed

• 1 other identifier: G172NU-S1
• Study Type: observational
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study was conducted to develop and validate integrated eye tracking and EEG measures for assessment of mild traumatic brain injury.

Conditions

Mild Traumatic Brain Injury

Keywords

Traumatic brain injury, concussion, eye tracking, EEG, fMRI, DTI, Neurocognition

Outcome Measures

Primary Outcomes (1)

• Saccadic RT

  Saccadic Response Time

  1 day (single time point)

Study Arms (3)

Control

Individuals without traumatic brain injury

Mild TBI

Individuals with mild traumatic brain injury

Moderate to Severe TBI

Individual with moderate to severe traumatic brain injury

Eligibility Criteria

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

Study Population

Participants will be recruited through USUHS, the Walter Reed National Military Medical Center, the National Intrepid Center of Excellence, Malcolm Grow Medical Center, the Washington DC VA Medical Center, VA outpatient treatment centers and Vet Centers in the greater Washington, D.C. area, Fort Belvoir, Fort Detrick and Fort Meade, public areas in the surrounding community, and in clinical settings such as such as concussion clinics, neurorehabilitation centers, and other local private practices.

You may qualify if:

• age 18 -55, ability to use left and right hands and right foot to complete cognitive and motor tasks without adaptive equipment, and fluent in English

You may not qualify if:

• history of severe TBI, history of neurological illness unrelated to TBI, vision problems that are uncorrected by contacts or glasses, history of psychotic disorder, or current homicidal or suicidal ideation or intent

Sponsors & Collaborators

• Uniformed Services University of the Health Sciences: lead

MeSH Terms

Conditions

Brain Concussion; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2018
• First Posted: December 17, 2018
• Study Start: April 15, 2015
• Primary Completion: March 15, 2017
• Study Completion: March 15, 2017
• Last Updated: December 17, 2018

Record last verified: 2017-06