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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 : October 2, 2019
Sponsor:
Collaborators:
Neurolign
Sync-Think, Inc.
Oculogica, Inc.
The Defense and Veterans Brain Injury Center
United States Department of Defense
Information provided by (Responsible Party):
Dr. John King, Walter Reed National Military Medical Center

Tracking Information
First Submitted Date  ICMJE May 11, 2017
First Posted Date  ICMJE May 16, 2017
Last Update Posted Date October 2, 2019
Actual Study Start Date  ICMJE September 18, 2017
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2017)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oculomotor Assessment of Traumatic Brain Injury (TBI)
Official Title  ICMJE Oculomotor Assessment of Traumatic Brain Injury (TBI)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Traumatic Brain Injury
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 15, 2017)
240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Must be DEERS eligible (military)
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: John King, Ph.D. 301-295-9281 john.e.king328.civ@mail.mil
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03156010
Other Study ID Numbers  ICMJE WRNMMC-2017-0045
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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.
Responsible Party Dr. John King, Walter Reed National Military Medical Center
Study Sponsor  ICMJE Walter Reed National Military Medical Center
Collaborators  ICMJE
  • Neurolign
  • Sync-Think, Inc.
  • Oculogica, Inc.
  • The Defense and Veterans Brain Injury Center
  • United States Department of Defense
Investigators  ICMJE
Principal Investigator: John King, Ph.D. WRNMMC
PRS Account Walter Reed National Military Medical Center
Verification Date September 2019

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