Disparity Driven Vergence in Mild Traumatic Brain Injury (mTBI)

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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)

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

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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