Disparity Driven Vergence in Mild Traumatic Brain Injury (mTBI)

Mild Traumatic Brain Injury Clinical Trial

Official title:

Examining Disparity Driven Vergence as a Potential Diagnostic Test for Mild Traumatic Brain Injury (mTBI)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03529799
• Other study ID #: 20180058
• Status: Terminated
• Phase: N/A
• Start date: April 20, 2018
• Est. completion date: September 25, 2019

Study information

• Verified date: June 2022
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: September 25, 2019
• Est. primary completion date: September 25, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Mild Traumatic Brain Injury
• Wounds and Injuries

Intervention

Device:
• I-PAS Goggles
Portable, head-mounted display goggle system with integrated eye capture technology

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Neurolign

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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