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NCT Number: NCT06142435

mTBI Identification and Monitoring Through Retinal Scanning

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.

Recruiting

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Boston, Massachusetts, 02215, United States

Location status: Recruiting

Location contact

Justin Shaka, MBA

CONTACT

[email protected]

857-600-0982

Nathan Cardoos, MD

CONTACT

[email protected]

617-414-6800

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age 18-45 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 consent
  • Able to participate in the examination, including the ability to follow simple instructions
  • Fluency in English or Spanish

Exclusion criteria

  • Glasgow Coma Scale score 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 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.

Other names: HITT

Primary outcomes

  1. TBI Detection

    Time frame: 1 day

    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.

Secondary outcomes

  1. TBI Monitor

    Time frame: 14 days

    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.

  2. TBI Monitor

    Time frame: 30 days

    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.

Sponsors and collaborators

Lead sponsor

Rebiscan, Inc.

Industry

Collaborators

  • Boston Medical Center

Registry information

Official study title

Mild Traumatic Brain Injury Identification and Monitoring Through Retional Scanning

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Nov 21, 2023
Registry last updated
May 20, 2026

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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