Disparity Driven Vergence in Mild Traumatic Brain Injury (mTBI)

June 3, 2022 updated by: Michael E. Hoffer, University of Miami

Examining Disparity Driven Vergence as a Potential Diagnostic Test for Mild Traumatic Brain Injury (mTBI)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pseudorandom Ternary Sequence of Frequency
Time Frame: 15 minutes
Pseudorandom Ternary Sequence of Frequency (reported in Hertz) will be measured via mergence testing using the IPAS goggles.
15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Collaborators

Neurolign

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 20, 2018

Primary Completion (ACTUAL)

September 25, 2019

Study Completion (ACTUAL)

September 25, 2019

Study Registration Dates

First Submitted

April 24, 2018

First Submitted That Met QC Criteria

May 7, 2018

First Posted (ACTUAL)

May 18, 2018

Study Record Updates

Last Update Posted (ACTUAL)

June 29, 2022

Last Update Submitted That Met QC Criteria

June 3, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20180058

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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