Diagnosis of mTBI in a Community Setting

NCT03539848 | Completed FDA Device

• 1 other identifier: 20180012
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

TBI; Community Setting; Mild TBI

Outcome Measures

Primary Outcomes (1)

• Number of participants with mTBI

  How many participants were detected to have mTBI following an injury.

  33 months

Secondary Outcomes (1)

• Time to recover

  33 months

Study Arms (2)

Subjects with mTBI

EXPERIMENTAL

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

Subjects with minor injuries

ACTIVE COMPARATOR

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

Interventions

I-PAS Goggles DEVICE

Portable, head-mounted display goggle system with integrated eye capture technology

Subjects with mTBI; Subjects with minor injuries

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• History of head injury characterized by any of the following:
• Resulting from penetrating trauma
• Resulting from an automobile accident with significant associated injuries
• Associated with a Glasgow Comma Scale Score of less than 13 at the time of injury
• Associated with a loss of consciousness period greater than 59 minutes
• Judged to be more than mild by Medical Staff
• Requiring admission to the hospital for any reason
• Associated with subdural or epidural hemorrhage
• Head injury history
• For control group - history of head injury within the last six months or currently experience any head injury symptoms at time of enrollment
• 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
• Presence of severe aphasia
• History of diagnosed neuropsychiatric disorders (e.g. hypochondriasis, major depression, schizophrenia)
• Documented neurodegenerative disorders
• Pregnancy \[Female candidates will be asked if they are pregnant\]

Sponsors & Collaborators

• University of Miami: lead
• Neurolign: collaborator

Study Sites (1)

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Concussion; Brain Injuries; Craniocerebral Trauma

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Head Injuries, Closed; Wounds, Nonpenetrating

Study Officials

• Michael Hoffer, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 15, 2018
• First Posted: May 29, 2018
• Study Start: August 1, 2018
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: September 2, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)