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Trial record 46 of 311 for:    Recruiting, Not yet recruiting, Available Studies | "Brain Injuries, Traumatic"

Disparity Driven Vergence in Mild Traumatic Brain Injury (mTBI)

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ClinicalTrials.gov Identifier: NCT03529799
Recruitment Status : Recruiting
First Posted : May 18, 2018
Last Update Posted : May 22, 2018
Sponsor:
Collaborator:
Neuro Kinetics
Information provided by (Responsible Party):
Michael E. Hoffer, University of Miami

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.

Condition or disease Intervention/treatment Phase
Mild Traumatic Brain Injury Device: I-PAS Goggles Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Examining Disparity Driven Vergence as a Potential Diagnostic Test for Mild Traumatic Brain Injury (mTBI)
Actual Study Start Date : April 20, 2018
Estimated Primary Completion Date : April 20, 2019
Estimated Study Completion Date : May 20, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Injured Participants
Participants with mild traumatic brain injury (mTBI) tested using the I-PAS goggles
Device: I-PAS Goggles
Portable, head-mounted display goggle system with integrated eye capture technology

Active Comparator: Uninjured Participants
Participants with no mild traumatic brain injury (mTBI) tested using the I-PAS goggles
Device: I-PAS Goggles
Portable, head-mounted display goggle system with integrated eye capture technology




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03529799


Contacts
Contact: Erin Williams 305-243-8959 ecw44@med.miami.edu

Locations
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Erin Williams         
Sponsors and Collaborators
University of Miami
Neuro Kinetics
Investigators
Principal Investigator: Michael Hoffer, MD University of Miami

Responsible Party: Michael E. Hoffer, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT03529799     History of Changes
Other Study ID Numbers: 20180058
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018

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: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Michael E. Hoffer, University of Miami:
mTBI
TBI
brain injury
concussion

Additional relevant MeSH terms:
Brain Injuries, Traumatic
Wounds and Injuries
Brain Injuries
Brain Concussion
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds, Nonpenetrating