mTBI Identification and Monitoring Through Retinal Scanning

Brain Injuries, Traumatic Clinical Trial

Official title:

Mild Traumatic Brain Injury Identification and Monitoring Through Retional Scanning

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06142435
• Other study ID #: BU-001
• Status: Recruiting
• Start date: August 15, 2023
• Est. completion date: August 31, 2024

Study information

• Verified date: November 2023
• Source: Rebiscan, Inc.
• Contact: n/a
• 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 60 TBI patients and 20 controls.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Age 18-45 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 consent

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 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 Injuries
• Brain Injuries, Traumatic

Intervention

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

Locations

Country	Name	City	State
United States	Boston Medical Center Concussion Clinic, Ryan Center for Sports Medicine & Rehabilitation at Boston University	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Rebiscan, Inc.	Boston Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TBI Detection	Patients who present with suspected TBI to the clinic will have their eyes scanned to identify whether the HITT device can accurately identify patients with TBI.	1 day
Secondary	TBI Monitor	Patients who present with suspected TBI to the clinic and had initially been tested for TBI detection will receive a second set of scans at 2 weeks to identify whether the HITT device can accurately identify patients with TBI.	14 days
Secondary	TBI Monitor	Patients who present with suspected TBI to the clinic and had initially been tested for TBI detection will receive a second set fo scans at one month to identify whether the HITT device can accurately identify patients with TBI.	30 days