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Completed

NCT Number: NCT03156010

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.

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Intrepid Center of Excellence

Bethesda, Maryland, 20889, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neuro Kinetics IPAS

Device

Testing with PAS device

Oculogica EyeBox

Device

Testing with Oculogica EyeBox device

SyncThink EyeSync Device

Device

Testing with SyncThink EyeSync device

Primary outcomes

  1. Area Under the Curve (AUC)

    Time frame: 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.

    Determination of sensitivity/specificity measure for each device using known characteristics of arms (i.e., history of TBI vs no history of TBI)

Sponsors and collaborators

Lead sponsor

Walter Reed National Military Medical Center

Fed

Collaborators

  • Neurolign
  • Oculogica, Inc.
  • Sync-Think, Inc.
  • TBICoE
  • United States Department of Defense

Registry information

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
May 16, 2017
Registry last updated
Aug 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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