Oculomotor Assessment of Traumatic Brain Injury (TBI)

NCT03156010 | Completed FDA Device

• 1 other identifier: WRNMMC-2017-0045
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

oculomotor testing

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

TBI Group

OTHER

Subjects with history of TBI will undergo testing with all three devices.

Device: Neuro Kinetics IPAS; Device: Oculogica EyeBox; Device: SyncThink EyeSync Device

Control Group

OTHER

Subjects with no history of TBI will undergo testing with all three devices.

Device: Neuro Kinetics IPAS; Device: Oculogica EyeBox; Device: SyncThink EyeSync Device

Interventions

Neuro Kinetics IPAS DEVICE

Testing with PAS device

Control Group; TBI Group

Oculogica EyeBox DEVICE

Testing with Oculogica EyeBox device

Control Group; TBI Group

SyncThink EyeSync Device DEVICE

Testing with SyncThink EyeSync device

Control Group; TBI Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Walter Reed National Military Medical Center: lead
• Neurolign: collaborator
• Sync-Think, Inc.: collaborator
• Oculogica, Inc.: collaborator
• TBICoE: collaborator
• United States Department of Defense: collaborator

Study Sites (1)

National Intrepid Center of Excellence

Bethesda, Maryland, 20889, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

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

Study Officials

• Louis French, PsyD

  NICoE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Audiologist

Model Details: All participants undergo testing with the same three devices. The order of devices will be semi-randomized to eliminate order effects.

Study Record Dates

• First Submitted: May 11, 2017
• First Posted: May 16, 2017
• Study Start: September 18, 2017
• Primary Completion: April 19, 2023
• Study Completion: April 19, 2023
• Last Updated: August 23, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)