mTBI Identification and Monitoring Through Retinal Scanning

NCT ID: NCT06142435

Last Updated: 2025-04-06

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-15
• Study Completion Date: 2025-08-31

Brief 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.

Conditions

Brain Injuries, Traumatic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Controls

Participants should not be part of the Intended Use Population. Subjects that present to the hospital, clinic, or emergency department, either as a patient or non-patient, with no history of head trauma and, are 18-45 years of age.

Head and Intraocular Trauma Tool

Intervention Type: DEVICE

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.

TBI-Suspected Patients

TBI participants 18-45 years of age, recruited from patients at a clinical research facility who present with head trauma. Clinical evaluation for the patient can be positive (target condition present) or negative (target condition absent) for mTBI. Testing will occur on Day-0, Day-14, and Day-30.

Head and Intraocular Trauma Tool

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

HITT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boston Medical Center

OTHER

Sponsor Role: collaborator

Rebiscan, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Boston Medical Center Concussion Clinic, Ryan Center for Sports Medicine & Rehabilitation at Boston University

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Nathan Cardoos, MD

Role: primary

ncardoos@bu.edu

617-414-6800

Justin Shaka, MBA

Role: backup

jgshaka@rebion.net

857-600-0982

Other Identifiers

BU-001

Identifier Type: -

Identifier Source: org_study_id