Diagnosis of mTBI in a Community Setting

NCT ID: NCT03539848

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2025-04-30

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.

Detailed Description

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. The study further looks at current metrics and compares their efficacy in both the diagnosis and prognostic value of individuals with mTBI.

Conditions

Traumatic Brain Injury; Mild Traumatic Brain Injury; Brain Injuries; Brain Injuries, Traumatic; Head Injury

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

I-PAS Goggles

Intervention Type: DEVICE

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

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.

Group Type: ACTIVE_COMPARATOR

I-PAS Goggles

Intervention Type: DEVICE

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

Interventions

I-PAS Goggles

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Neurolign

INDUSTRY

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Michael E. Hoffer

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Hoffer, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami Miller School of Medicine

Miami, Florida, United States

Countries

United States

Other Identifiers

20180012

Identifier Type: -

Identifier Source: org_study_id