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Disparity Driven Vergence in Mild Traumatic Brain Injury (mTBI)

Primary Purpose

Mild Traumatic Brain Injury

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
I-PAS Goggles
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Mild Traumatic Brain Injury focused on measuring mTBI, TBI, brain injury, concussion

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Miami

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Injured Participants

Uninjured Participants

Arm Description

Participants with mild traumatic brain injury (mTBI) tested using the I-PAS goggles

Participants with no mild traumatic brain injury (mTBI) tested using the I-PAS goggles

Outcomes

Primary Outcome Measures

Pseudorandom Ternary Sequence of Frequency
Pseudorandom Ternary Sequence of Frequency (reported in Hertz) will be measured via mergence testing using the IPAS goggles.

Secondary Outcome Measures

Full Information

First Posted
April 24, 2018
Last Updated
June 3, 2022
Sponsor
University of Miami
Collaborators
Neurolign
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1. Study Identification

Unique Protocol Identification Number
NCT03529799
Brief Title
Disparity Driven Vergence in Mild Traumatic Brain Injury (mTBI)
Official Title
Examining Disparity Driven Vergence as a Potential Diagnostic Test for Mild Traumatic Brain Injury (mTBI)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Terminated
Why Stopped
COVID-19 pandemic
Study Start Date
April 20, 2018 (Actual)
Primary Completion Date
September 25, 2019 (Actual)
Study Completion Date
September 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
Neurolign

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Traumatic Brain Injury
Keywords
mTBI, TBI, brain injury, concussion

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Injured Participants
Arm Type
Experimental
Arm Description
Participants with mild traumatic brain injury (mTBI) tested using the I-PAS goggles
Arm Title
Uninjured Participants
Arm Type
Active Comparator
Arm Description
Participants with no mild traumatic brain injury (mTBI) tested using the I-PAS goggles
Intervention Type
Device
Intervention Name(s)
I-PAS Goggles
Intervention Description
Portable, head-mounted display goggle system with integrated eye capture technology
Primary Outcome Measure Information:
Title
Pseudorandom Ternary Sequence of Frequency
Description
Pseudorandom Ternary Sequence of Frequency (reported in Hertz) will be measured via mergence testing using the IPAS goggles.
Time Frame
15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Hoffer, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Disparity Driven Vergence in Mild Traumatic Brain Injury (mTBI)

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