An observational study in Brain Injuries, Traumatic, sponsored by Rebiscan, Inc.. Completed at 1 site in United States. Open to participants aged 13 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Rebiscan, Inc. · Observational
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.
1,775 studies on the registry are indexed under Brain Injuries, Traumatic; 449 are open to participants now.
This study's enrollment of 10 is below the median of 118 across 562 observational studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →Rebiscan, Inc. is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Able to provide informed consent
Exclusion Criteria:
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.
Device: Head and Intraocular Trauma Tool · Diagnostic Test: SCAT-5
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.
Device: Head and Intraocular Trauma Tool · Diagnostic Test: SCAT-5
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.
Also known as: HITT
Participant is to complete Step 2 (Symptom Evaluation) and Step 3 (Cognitive Screening) of SCAT-5 test.
Also known as: Sport Concussion Assessment Tool - 5th Edition
TBI Detection
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.
Time frame: 1 day
TBI Monitor
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.
Time frame: 14 days
Plan to share: Yes — Aggregate data and individual test reports will be made available to the HITT device manufacturer to better understand its performance at identifying TBI. Personal identifiable data will not be shared with anyone outside of the University of Pennsylvania.
Supporting information: Study protocol, Csr
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Rebiscan, Inc.