NCT03156010

Oculomotor Assessment of Traumatic Brain Injury (TBI)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 201 (actual)
• Sponsor: Walter Reed National Military Medical Center · Federal
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of the proposed study is to compare the sensitivity and specificity of three oculomotor test devices in normal subjects versus subjects with history of TBI. The study is designed as a prospective research project in which a group of 120 normal controls without a history of TBI will be compared to another group of 120 participants (total of 240) who have a confirmed history of TBI. Each participant will complete the TBI assessment protocol for each of three separate devices (Neuro Kinetics, SyncThink, and Oculogica). The order of the devices will be counter-balanced across participants. Participants will also be screened for vestibular migraine and visual vertigo, which are two conditions that influence oculo-vestibular perception in normal and TBI patients and might influence the results from the three oculomotor devices. Data from each device will be utilized to perform AUC analyses to determine the respective sensitivity and specificity for each.

Conditions

• Traumatic Brain Injury

Interventions

Type	Name	Description
DEVICE	Neuro Kinetics IPAS	Testing with PAS device
DEVICE	Oculogica EyeBox	Testing with Oculogica EyeBox device
DEVICE	SyncThink EyeSync Device	Testing with SyncThink EyeSync device

Timeline

• Start date: 2017-09-18
• Primary completion: 2023-04-19
• Completion: 2023-04-19
• First posted: 2017-05-16
• Last updated: 2023-08-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study