Clinical trial NCT05092282: HITT for the Identification of Mild Traumatic Brain Injury
Official title: Head and Intraocular Trauma Tool (HITT) for the Identification of Mild Traumatic Brain Injury
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Brain Injuries, Traumatic
Lead sponsor: Rebiscan, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Pennsylvania
First posted: 2021-10-25
Enrollment: 200
Sex: ALL
Minimum age (years): 13
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population including target participants that enroll within two weeks of blunt head trauma, with a Glasgow Coma Scale score equal to or greater than thirteen. A minimum of one hundred Target Condition subjects will be enrolled. All studies will be completed on the day of enrollment.

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 100 TBI patients and 100 controls.


Eligibility criteria: 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

Primary outcomes:
measure: TBI Detection
timeFrame: 1 day
Secondary outcomes:
measure: TBI Monitor
timeFrame: 14 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Penn Presbyterian Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Ramon Diaz-Arrastia, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: