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Disparity Driven Vergence in Mild Traumatic Brain Injury (mTBI)
Examining Disparity Driven Vergence as a Potential Diagnostic Test for Mild Traumatic Brain Injury (mTBI)
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 20, 2018
CompletedFirst Submitted
Initial submission to the registry
April 24, 2018
CompletedFirst Posted
Study publicly available on registry
May 18, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 25, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 25, 2019
CompletedResults Posted
Study results publicly available
June 29, 2022
CompletedJune 29, 2022
June 1, 2022
1.4 years
April 24, 2018
April 15, 2022
June 3, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pseudorandom Ternary Sequence of Frequency
Pseudorandom Ternary Sequence of Frequency (reported in Hertz) will be measured via mergence testing using the IPAS goggles.
15 minutes
Study Arms (2)
Injured Participants
EXPERIMENTALParticipants with mild traumatic brain injury (mTBI) tested using the I-PAS goggles
Uninjured Participants
ACTIVE COMPARATORParticipants with no mild traumatic brain injury (mTBI) tested using the I-PAS goggles
Interventions
Portable, head-mounted display goggle system with integrated eye capture technology
Eligibility Criteria
You may qualify if:
- Age 18 to 65
- Both females and males
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Miamilead
- Neuroligncollaborator
Study Sites (1)
University of Miami
Miami, Florida, 33136, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Michael Hoffer
- Organization
- University of Miami
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Hoffer, MD
University of Miami
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 24, 2018
First Posted
May 18, 2018
Study Start
April 20, 2018
Primary Completion
September 25, 2019
Study Completion
September 25, 2019
Last Updated
June 29, 2022
Results First Posted
June 29, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share