Disparity Driven Vergence in Mild Traumatic Brain Injury (mTBI)

University of Miami

Status: Terminated

Conditions: Mild Traumatic Brain Injury

Treatments: Device: I-PAS Goggles

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03529799

20180058

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Injured Participants

Experimental group

Description:

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

Treatment:

Device: I-PAS Goggles

Uninjured Participants

Active Comparator group

Description:

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

Treatment:

Device: I-PAS Goggles