Oculomotor Assessment of Traumatic Brain Injury (TBI)

Traumatic Brain Injury Clinical Trial

Official title:

Oculomotor Assessment of Traumatic Brain Injury (TBI)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03156010
• Other study ID #: WRNMMC-2017-0045
• Status: Completed
• Phase: N/A
• Start date: September 18, 2017
• Est. completion date: April 19, 2023

Study information

• Verified date: August 2023
• Source: Walter Reed National Military Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: April 19, 2023
• Est. primary completion date: April 19, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Device:
• Neuro Kinetics IPAS
Testing with PAS device
• Oculogica EyeBox
Testing with Oculogica EyeBox device
• SyncThink EyeSync Device
Testing with SyncThink EyeSync device

Locations

Country	Name	City	State
United States	National Intrepid Center of Excellence	Bethesda	Maryland

Sponsors (6)

Lead Sponsor	Collaborator
Walter Reed National Military Medical Center	Neurolign, Oculogica, Inc., Sync-Think, Inc., TBICoE, United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.