NCT03539848

Diagnosis of mTBI in a Community Setting

The Use of a Portable 3D Head Mounted Display (HMD) With Integrated Eye Capture Technology (IPAS Goggles) for the Diagnosis of Mild Traumatic Brain Injury (mTBI) in a Community Setting

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to test whether a portable goggle system (I-PAS) is good at diagnosing mild traumatic brain injury (mTBI) in a community setting. The goal is to determine whether the IPAS goggle system can be used reliably in an urgent care or emergency department setting.

Detailed description

The purpose of this research study is to test whether a portable goggle system (I-PAS) is good at diagnosing mild traumatic brain injury (mTBI) in a community setting. The goal is to determine whether the IPAS goggle system can be used reliably in an urgent care or emergency department setting. The study further looks at current metrics and compares their efficacy in both the diagnosis and prognostic value of individuals with mTBI.

Conditions

• Traumatic Brain Injury
• Mild Traumatic Brain Injury
• Brain Injuries
• Brain Injuries, Traumatic
• Head Injury

Interventions

Type	Name	Description
DEVICE	I-PAS Goggles	Portable, head-mounted display goggle system with integrated eye capture technology

Timeline

• Start date: 2018-08-01
• Primary completion: 2025-04-30
• Completion: 2025-04-30
• First posted: 2018-05-29
• Last updated: 2025-09-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study