Oculomotor Assessment of Traumatic Brain Injury (TBI)

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

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

Sponsors & Collaborators

• Neurolign

  collaborator INDUSTRY

• Sync-Think, Inc.

  collaborator INDUSTRY

• Oculogica, Inc.

  collaborator INDUSTRY

• TBICoE

  collaborator UNKNOWN

• United States Department of Defense

  collaborator FED

• Walter Reed National Military Medical Center

  lead FED

Principal Investigators

• Louis French, PsyD · NICoE

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-09-18

Primary Completion

2023-04-19

Completion

2023-04-19

FDA Device

Yes

Countries

• United States

Study Locations