Diagnosis of mTBI in a Community Setting

Traumatic Brain Injury Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03539848
• Other study ID #: 20180012
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: September 30, 2024

Study information

• Verified date: February 2024
• Source: University of Miami
• Contact: Erin Williams
• Phone: 305-243-8959
• Email: ecw44[@]med.miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Craniocerebral Trauma
• Head Injury
• Mild Traumatic Brain Injury
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Device:
• I-PAS Goggles
Portable, head-mounted display goggle system with integrated eye capture technology

Locations

Country	Name	City	State
United States	University of Miami Miller School of Medicine	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Neurolign

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with mTBI	How many participants were detected to have mTBI following an injury.	33 months
Secondary	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