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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03156010
Other study ID # WRNMMC-2017-0045
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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.
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