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Active, Not Recruiting

NCT Number: NCT05092282

HITT for the Identification of Mild Traumatic Brain Injury

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Brain Injuries, Traumatic Brain Diseases Brain Injuries Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

13 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 13-45 years
  • Presents to the facility within 2 weeks of head trauma
  • Able to provide informed consent
  • If minor, then able to provide parental consent and minor assent
  • Able to participate in the examination, including the ability to follow simple instructions
  • Fluency in English or Spanish

Exclusion criteria

  • Glasgow Coma Scale score of equal to or less than 13 at the time of study enrollment
  • Under the influence of alcohol or drugs
  • Previous eye surgery
  • Visual acuity known to be 20/200 or less in either eye
  • Known strabismus, amblyopia (lazy eye), or double vision
  • Known eye movement disorder, including nystagmus
  • Known optic nerve disease, including papilledema or optic neuropathy
  • Known retinal disease, including macular degeneration or retinal degeneration
  • Known cataract
  • History of neurosurgery
  • History of stroke/brain hemorrhage, brain tumor, or epilepsy
  • Any head trauma requiring medical attention from a physician within the last 6 months
  • Diagnosed dementia or cognitive impairment requiring assistance for daily living
  • Other condition(s) under the care of a neurologist
  • Psychiatric hospitalization in the last 90 days
  • Subject considered unsuitable for participation in this clinical trial by PI, treating clinician, or study research staff
  • Any minor brain injury regardless of loss of consciousness

Treatment and study plan

Head and Intraocular Trauma Tool

Device

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.

Other names: HITT

SCAT-5

Diagnostic Test

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

Other names: Sport Concussion Assessment Tool - 5th Edition

Primary outcomes

  1. TBI Detection

    Time frame: 1 day

    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.

Secondary outcomes

  1. TBI Monitor

    Time frame: 14 days

    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.

Sponsors and collaborators

Lead sponsor

Rebiscan, Inc.

Industry

Collaborators

  • University of Pennsylvania

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Oct 25, 2021
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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