Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Oculomotor Assessment of Traumatic Brain Injury (TBI)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2017 by Walter Reed National Military Medical Center
Sponsor:
Collaborators:
Neuro Kinetics
SyncThink
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
ClinicalTrials.gov Identifier:
NCT03156010
First received: May 11, 2017
Last updated: May 15, 2017
Last verified: May 2017
  Purpose
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.

Condition Intervention
Traumatic Brain Injury
Device: Neuro Kinetics IPAS
Device: Oculogica EyeBox
Device: SyncThink EyeSync Device

Study Type: Interventional
Study Design: 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: No masking
Primary Purpose: Diagnostic
Official Title: Oculomotor Assessment of Traumatic Brain Injury (TBI)

Resource links provided by NLM:


Further study details as provided by Walter Reed National Military Medical Center:

Primary Outcome Measures:
  • 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)


Estimated Enrollment: 240
Anticipated Study Start Date: June 2017
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
TBI Group
Subjects with history of TBI will undergo testing with all three devices.
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
Control Group
Subjects with no history of TBI will undergo testing with all three devices.
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03156010

Contacts
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

Locations
United States, Maryland
National Intrepid Center of Excellence Not yet recruiting
Bethesda, Maryland, United States, 20889
Contact: John E King, Ph.D.    301-204-0277    john.e.king328.civ@mail.mil   
Contact: Chantele R Friend, M.S.    301-295-9281    chantele.r.friend.ctr@mail.mil   
Sponsors and Collaborators
Walter Reed National Military Medical Center
Neuro Kinetics
SyncThink
Oculogica, Inc.
The Defense and Veterans Brain Injury Center
United States Department of Defense
Investigators
Principal Investigator: John King, Ph.D. WRNMMC
  More Information

Responsible Party: Dr. John King, Audiologist, Walter Reed National Military Medical Center
ClinicalTrials.gov Identifier: NCT03156010     History of Changes
Other Study ID Numbers: WRNMMC-2017-0045
Study First Received: May 11, 2017
Last Updated: May 15, 2017
Individual Participant Data  
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.

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

Keywords provided by Walter Reed National Military Medical Center:
oculomotor testing

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on May 25, 2017