Diagnosis of mTBI in a Community Setting
NCT03539848 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2025-09-02
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.
Conditions
- Traumatic Brain Injury
- Mild Traumatic Brain Injury
- Brain Injuries
- Brain Injuries, Traumatic
- Head Injury
Interventions
- DEVICE
-
I-PAS Goggles
Portable, head-mounted display goggle system with integrated eye capture technology
Sponsors & Collaborators
-
Neurolign
collaborator INDUSTRY -
University of Miami
lead OTHER
Principal Investigators
-
Michael Hoffer, MD · University of Miami
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-08-01
- Primary Completion
- 2025-04-30
- Completion
- 2025-04-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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