Oculomotor Assessment of Traumatic Brain Injury (TBI)

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.

Study Overview

• Status: Completed
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Device: Neuro Kinetics IPAS; Device: Oculogica EyeBox; Device: SyncThink EyeSync Device

• Study Type: Interventional
• Enrollment (Actual): 201
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: John King, Ph.D.; Phone Number: 301-295-9281; Email: john.e.king328.civ@mail.mil

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20889
      • National Intrepid Center of Excellence

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

All participants must be DEERS eligible, no exceptions!

Inclusion Criteria:

• Must be between 18 and 45 at time of screening (upper age restriction is to prevent confounding with age-related physiological changes).
• Must be able to provide written informed consent.
• Must be able to read and understand questionnaires and consent forms.
• Must have corrected binocular acuity of at least 20/40 for near distance with or without single-power corrective lenses or contacts and absent of ocular injury or disease.

Control Group - No history of TBI or any history of severe or penetrating TBI

TBI Group - Must have a documented history of a TBI occurring within the last 10 years.

Exclusion Criteria:

• Current or previous neurological disease, including: stroke, congenital brain malformation, degenerative illness such as multiple sclerosis, epilepsy or seizure (other than febrile seizure).
• Current or previous ocular disease/injury, including: Glaucoma or increased pressure in the eyes, structural damage to ocular tract and ocular cortex, etc.
• History of vestibular disorder (e.g., with symptoms of clinical vertigo)
• Binocular vision not correctable to 20/40 for near distance
• Use of tobacco or caffeinated products less than four hours before test session
• Consumption of alcohol within past 24 hours

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: TBI Group; Subjects with history of TBI will undergo testing with all three devices.	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
Other: Control Group; Subjects with no history of TBI will undergo testing with all three devices.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Curve (AUC)	Determination of sensitivity/specificity measure for each device using known characteristics of arms (i.e., history of TBI vs no history of TBI)	Single test session (1.5 hours) - all testing performed at time of study enrollment, will be reported at conclusion of data collection as all data is required to generate AUCs.

Collaborators and Investigators

• Sponsor: Walter Reed National Military Medical Center
• Collaborators: United States Department of Defense; Oculogica, Inc.; Sync-Think, Inc.; Neurolign; TBICoE
• Investigators: Principal Investigator: Louis French, PsyD, NICoE

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2017
• Primary Completion (Actual): April 19, 2023
• Study Completion (Actual): April 19, 2023

Study Registration Dates

• First Submitted: May 11, 2017
• First Submitted That Met QC Criteria: May 15, 2017
• First Posted (Actual): May 16, 2017

Study Record Updates

• Last Update Posted (Actual): August 23, 2023
• Last Update Submitted That Met QC Criteria: August 21, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: oculomotor testing
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: WRNMMC-2017-0045

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared. All data from project will be shared in de-identified format as group data, not IPD.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes