Disparity Driven Vergence in Mild Traumatic Brain Injury (mTBI)

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-20

Study Completion Date

2019-09-25

Brief Summary

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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.

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Detailed Description

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Conditions

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Mild Traumatic Brain Injury

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Injured Participants

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

Group Type EXPERIMENTAL

I-PAS Goggles

Intervention Type DEVICE

Portable, head-mounted display goggle system with integrated eye capture technology

Uninjured Participants

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

Group Type ACTIVE_COMPARATOR

I-PAS Goggles

Intervention Type DEVICE

Portable, head-mounted display goggle system with integrated eye capture technology

Interventions

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I-PAS Goggles

Portable, head-mounted display goggle system with integrated eye capture technology

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes