Head and Intraocular Trauma Tool for the Identification of Mild Traumatic Brain Injury

Brain Injuries, Traumatic Clinical Trial

Official title:

Head and Intraocular Trauma Tool for the Identification of Mild Traumatic Brain Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05092295
• Other study ID #: 002_Q201535
• Status: Recruiting
• Start date: December 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Rebiscan, Inc.
• Contact: Damon R Kuehl, MD
• Phone: 540-981-7000
• Email: drkuehl[@]carilionclinic.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Rebion has developed a device, the Rebion trauma tool (referred to as the head and intraocular trauma tool, or "HITT"), that detects ocular fixation and alignment using a binocular retinal scan. Preliminary data obtained from hospitalized patients with a clinically-confirmed traumatic brain injury (TBI) and uninjured controls indicates that the device can detect changes in ocular fixation, alignment, and saccades that are related to brain injury. This study seeks to evaluate the ability of the Rebion trauma tool to assess perturbations in eye movements resulting from TBI. The study will enroll 100 TBI patients and 100 controls.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Gender: All
• Age group: 13 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Age 13-45 years

2. Presents to the facility within 2 weeks of head trauma

3. Able to provide informed consent

• If minor, then able to provide parental consent and minor assent

4. Able to participate in the examination, including the ability to follow simple instructions

5. Fluency in English or Spanish

Exclusion Criteria:

1. Glasgow Coma Scale score of equal to or less than 13 at the time of study enrollment

2. Under the influence of alcohol or drugs

3. Previous eye surgery

4. Visual acuity known to be 20/200 or less in either eye

5. Known strabismus, amblyopia (lazy eye), or double vision

6. Known eye movement disorder, including nystagmus

7. Known optic nerve disease, including papilledema or optic neuropathy

8. Known retinal disease, including macular degeneration or retinal degeneration

9. Known cataract

10. History of neurosurgery

11. History of stroke/brain hemorrhage, brain tumor, or epilepsy

12. Any head trauma requiring medical attention from a physician within the last 6 months

13. Diagnosed dementia or cognitive impairment requiring assistance for daily living

14. Other condition(s) under the care of a neurologist

15. Psychiatric hospitalization in the last 90 days

16. Subject considered unsuitable for participation in this clinical trial by PI, treating clinician, or study research staff

17. Any minor brain injury regardless of loss of consciousness

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Wounds and Injuries

Intervention

Device:
• Head and Intraocular Trauma Tool
HITT device to scan eyes of participants up to 3 times (~45 seconds each) at time of admittance to study. Participant is to place chin in chin-rest and fixate on illuminated light on device.

Diagnostic Test:
• SCAT-5
Participant is to complete Step 2 (Symptom Evaluation) and Step 3 (Cognitive Screening) of SCAT-5 test.

Locations

Country	Name	City	State
United States	Carilion Roanoke Memorial Hospital	Roanoke	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Rebiscan, Inc.	Carilion Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TBI Detection	Patients who have diagnosed TBI and are admitted to the hospital for treatment will have their eyes scanned to identify whether the HITT device can accurately identify patients with TBI.	1 day
Secondary	TBI Monitor	Patients who have remained in the hospital for TBI and received initial HITT device scan will receive a second set of scans at 2 weeks to identify whether the HITT device can accurately identify patients with TBI.	14 days