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Diagnosis of mTBI in a Community Setting

Primary Purpose

Traumatic Brain Injury, Mild Traumatic Brain Injury, Brain Injuries

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
I-PAS Goggles
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Traumatic Brain Injury focused on measuring TBI, Community Setting, Mild TBI

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Miami Miller School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Subjects with mTBI

Subjects with minor injuries

Arm Description

Individuals who come to the emergency department or urgent/acute care facility with an mTBI will undergo testing with the I-PAS Goggles.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 15, 2018
Last Updated
March 14, 2023
Sponsor
University of Miami
Collaborators
Neurolign
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1. Study Identification

Unique Protocol Identification Number
NCT03539848
Brief Title
Diagnosis of mTBI in a Community Setting
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
May 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
Neurolign

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury, Mild Traumatic Brain Injury, Brain Injuries, Brain Injuries, Traumatic, Head Injury
Keywords
TBI, Community Setting, Mild TBI

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Subjects with mTBI
Arm Type
Experimental
Arm Description
Individuals who come to the emergency department or urgent/acute care facility with an mTBI will undergo testing with the I-PAS Goggles.
Arm Title
Subjects with minor injuries
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
I-PAS Goggles
Intervention Description
Portable, head-mounted display goggle system with integrated eye capture technology
Primary Outcome Measure Information:
Title
Number of participants with mTBI
Description
How many participants were detected to have mTBI following an injury.
Time Frame
33 months
Secondary Outcome Measure Information:
Title
Time to recover
Description
Measuring the time (days) it takes for readiness to return to normal activity after a head injury for participants with a detected mTBI
Time Frame
33 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Participants must meet one of the following inclusion criteria: 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. Exclusion Criteria: 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] Prior disorders of hearing and balance including: Meniere's disease Multiple sclerosis Vestibular neuritis Vestibular schwannoma Sudden sensorineural hearing loss History of Cerebrovascular disorders History of ear operation other than myringotomy and tube placement in the past Systemic disorders to include chronic renal failure, cirrhosis of the liver, autoimmune disease, heart disease, lung disease, or severe arthritis Children Individuals who cannot provide informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erin Williams
Phone
305-243-8959
Email
ecw44@med.miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Hoffer, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael E Hoffer, MD
Phone
305-243-3564
Email
michael.hoffer@miami.edu
First Name & Middle Initial & Last Name & Degree
Michael Hoffer, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Diagnosis of mTBI in a Community Setting

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