HITT for the Identification of Mild Traumatic Brain Injury

Rebiscan

Status: Active, not recruiting

Conditions: Brain Injuries, Traumatic

Treatments: Device: Head and Intraocular Trauma Tool; Diagnostic Test: SCAT-5

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05092282

001_Q201535

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 13 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

TBI Patients

Description:

TBI participants 13 to 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. Enrollment is to occur within 2 weeks of the incident injury.

Treatment:

Diagnostic Test: SCAT-5

Device: Head and Intraocular Trauma Tool

Controls

Description:

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.

Treatment:

Diagnostic Test: SCAT-5

Device: Head and Intraocular Trauma Tool