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Disparity Driven Vergence in Mild Traumatic Brain Injury (mTBI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03529799
Recruitment Status : Recruiting
First Posted : May 18, 2018
Last Update Posted : June 26, 2020
Sponsor:
Collaborator:
Neurolign
Information provided by (Responsible Party):
Michael E. Hoffer, University of Miami

Tracking Information
First Submitted Date  ICMJE April 24, 2018
First Posted Date  ICMJE May 18, 2018
Last Update Posted Date June 26, 2020
Actual Study Start Date  ICMJE April 20, 2018
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2018)
Feasibility of expanded frequencies for vergence testing [ Time Frame: 15 minutes ]
Eyes will be examined under conditions that cause the eyes to move towards each other (convergence) and away from each other (divergence). The degrees of deviation of the eyes from center expressed in degrees and the speed of eye motion expressed in total number of seconds to complete motion will be examined in response to a variety of different stimuli designed to create different amounts of convergence and divergence (stimuli will be a virtual light dot moving towards or away from the eyes at different speeds and different distances). The speed, direction, and distance of the dot movement will be random for each participant.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2018)
  • Toxicity Level Associated with Goggle Use [ Time Frame: 1 hour post-intervention ]
    Toxicity level will be measured by giving participants a Medical Symptom/Toxicity Questionnaire (MSQ) post-goggle intervention. Scores of 10-50 would be considered mild toxicity, 50-100 moderate, 100+ severe. The number of individuals in each category will be collected.
  • Vergence Testing Values [ Time Frame: 15 minutes ]
    Collection of vergence battery test scores that focus on an object moving forward and backward using a random sequence at different frequencies. Resulting in ordinal value scores from 0-100, increasing in accuracy. Ordinal values will be collected for each subject to establish normal and abnormal ranges.
  • Comparing Vergence Testing Values [ Time Frame: 15 minutes ]
    Comparing the vergence battery test scores that focus on an object moving forward and backward using a random sequence at different frequencies for normal participants versus mTBI participants. Test performance of this task in normals as well as those with mTBI and compare the outcomes
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Disparity Driven Vergence in Mild Traumatic Brain Injury (mTBI)
Official Title  ICMJE Examining Disparity Driven Vergence as a Potential Diagnostic Test for Mild Traumatic Brain Injury (mTBI)
Brief Summary This study aims to determine the validity and safety of disparity driven vergence using a portable goggle system (I-PAS) using a pseudorandom ternary sequence of frequencies for testing.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Mild Traumatic Brain Injury
Intervention  ICMJE Device: I-PAS Goggles
Portable, head-mounted display goggle system with integrated eye capture technology
Study Arms  ICMJE
  • Experimental: Injured Participants
    Participants with mild traumatic brain injury (mTBI) tested using the I-PAS goggles
    Intervention: Device: I-PAS Goggles
  • Active Comparator: Uninjured Participants
    Participants with no mild traumatic brain injury (mTBI) tested using the I-PAS goggles
    Intervention: Device: I-PAS Goggles
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 7, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18 to 65
  • Both females and males

Exclusion Criteria:

  • Central processing disorder
  • Impaired vision without corrective lenses (max 20/60 uncorrected)
  • Moderate to severe hearing loss (>55 decibels (dB) pure tone audiometry (PTA), <50% word identification)
  • Vestibular disorder except for patients recruited for subjects recruited with a history of mild traumatic brain injury to compare to normal participants
  • History of ear surgery other than myringotomy with or without tube placement
  • Pregnant women
  • Prisoners
  • Adults unable to consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Erin Williams 305-243-8959 ecw44@med.miami.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03529799
Other Study ID Numbers  ICMJE 20180058
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
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael E. Hoffer, University of Miami
Study Sponsor  ICMJE University of Miami
Collaborators  ICMJE Neurolign
Investigators  ICMJE
Principal Investigator: Michael Hoffer, MD University of Miami
PRS Account University of Miami
Verification Date June 2020

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