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

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.

Study Overview

• Status: Recruiting
• Conditions: Brain Injuries; Brain Injuries, Traumatic; Traumatic Brain Injury; Mild Traumatic Brain Injury; Head Injury
• Intervention / Treatment: Device: I-PAS Goggles

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Erin Williams; Phone Number: 305-243-8959; Email: ecw44@med.miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami Miller School of Medicine
      • Principal Investigator: Michael Hoffer, MD
      • Contact: Michael E Hoffer, MD; Phone Number: 305-243-3564; Email: michael.hoffer@miami.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

Participants must meet one of the following inclusion criteria:

1. Males and females from 18-50 years of age who present to the emergency department or urgent/acute care facility at the University of Miami Hospital, Jackson Memorial Hospital, or by direct referral to the clinic with a history of all of the following: 1) Blow or impact to head, 2) Period of loss or alteration of consciousness, 3) Neurosensory symptoms, and 4) Diagnosis by Emergency Room Staff or Medical Staff of having suffered an mTBI/Concussion.
2. An age- and sex- matched control group also recruited from emergency department or urgent/acute care facility at the University of Miami Hospital, Jackson Memorial Hospital, or by direct referral to the clinic. These will include individuals with minor injuries (e.g ankle sprains, minor knee injuries, etc.) not involving the head and not requiring admission to the hospital.

Exclusion Criteria:

1. History of head injury characterized by any of the following:

   1. Resulting from penetrating trauma
   2. Resulting from an automobile accident with significant associated injuries
   3. Associated with a Glasgow Comma Scale Score of less than 13 at the time of injury
   4. Associated with a loss of consciousness period greater than 59 minutes
   5. Judged to be more than mild by Medical Staff
   6. Requiring admission to the hospital for any reason
   7. Associated with subdural or epidural hemorrhage

2. Head injury history

   1. For control group - history of head injury within the last six months or currently experience any head injury symptoms at time of enrollment
   2. For head injured group - history of head injury within the last three months or experiencing head injury symptoms immediately prior to the current head injury
3. Presence of severe aphasia
4. History of diagnosed neuropsychiatric disorders (e.g. hypochondriasis, major depression, schizophrenia)
5. Documented neurodegenerative disorders
6. Pregnancy [Female candidates will be asked if they are pregnant]

7. Prior disorders of hearing and balance including:

   1. Meniere's disease
   2. Multiple sclerosis
   3. Vestibular neuritis
   4. Vestibular schwannoma
   5. Sudden sensorineural hearing loss
8. History of Cerebrovascular disorders
9. History of ear operation other than myringotomy and tube placement in the past
10. Systemic disorders to include chronic renal failure, cirrhosis of the liver, autoimmune disease, heart disease, lung disease, or severe arthritis
11. Children
12. Individuals who cannot provide informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subjects with mTBI; Individuals who come to the emergency department or urgent/acute care facility with an mTBI will undergo testing with the I-PAS Goggles.	Device: I-PAS Goggles; Portable, head-mounted display goggle system with integrated eye capture technology
Active Comparator: Subjects with minor injuries; Individuals who come to the emergency department or urgent/acute care facility with minor injuries (such as ankle sprains or knee sprains) will undergo testing with the I-PAS Goggles.	Device: I-PAS Goggles; Portable, head-mounted display goggle system with integrated eye capture technology

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with mTBI	How many participants were detected to have mTBI following an injury.	33 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to recover	Measuring the time (days) it takes for readiness to return to normal activity after a head injury for participants with a detected mTBI	33 months

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: Neurolign
• Investigators: Principal Investigator: Michael Hoffer, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: May 15, 2018
• First Submitted That Met QC Criteria: May 16, 2018
• First Posted (Actual): May 29, 2018

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: TBI; Mild TBI; Community Setting
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Craniocerebral Trauma; Brain Concussion
• Other Study ID Numbers: 20180012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No