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Oculomotor Assessment of Traumatic Brain Injury (TBI)

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ClinicalTrials.gov Identifier: NCT03156010
Recruitment Status : Recruiting
First Posted : May 16, 2017
Last Update Posted : September 25, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

May 11, 2017
May 16, 2017
September 25, 2017
September 18, 2017
June 2019   (Final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT03156010 on ClinicalTrials.gov Archive Site
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Oculomotor Assessment of Traumatic Brain Injury (TBI)
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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Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
All participants undergo testing with the same three devices. The order of devices will be semi-randomized to eliminate order effects.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Traumatic Brain Injury
  • 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
  • TBI Group
    Subjects with history of TBI will undergo testing with all three devices.
    Interventions:
    • Device: Neuro Kinetics IPAS
    • Device: Oculogica EyeBox
    • Device: SyncThink EyeSync Device
  • Control Group
    Subjects with no history of TBI will undergo testing with all three devices.
    Interventions:
    • Device: Neuro Kinetics IPAS
    • Device: Oculogica EyeBox
    • Device: SyncThink EyeSync Device
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
240
June 2019
June 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
Yes
Contact: John King, Ph.D. 301-204-0277 john.e.king328.civ@mail.mil
Contact: Chantele Friend, M.S. 301-295-9281 chantele.r.friend.ctr@mail.mil
United States
 
 
NCT03156010
WRNMMC-2017-0045
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Plan to Share IPD: No
Plan Description: IPD will not be shared. All data from project will be shared in de-identified format as group data, not IPD.
Dr. John King, Walter Reed National Military Medical Center
Walter Reed National Military Medical Center
  • Neuro Kinetics
  • SyncThink
  • Oculogica, Inc.
  • The Defense and Veterans Brain Injury Center
  • United States Department of Defense
Principal Investigator: John King, Ph.D. WRNMMC
Walter Reed National Military Medical Center
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP