Brain Injuries, TraumaticNCT05092295
Head and Intraocular Trauma Tool for the Identification of Mild Traumatic Brain Injury
An observational study of Brain Injuries, Traumatic, run by Rebiscan, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 45 years
- Conditions the study is for
- Brain Injuries, Traumatic
- What is being tested?
- Head and Intraocular Trauma Tool and SCAT-5
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2021to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 45 years
- All sexes
- Child, Adult
Study population: Target participants for the study population include those within 2 weeks of blunt head trauma, with a Glasgow Coma Scale score of greater than or equal to thirteen. A minimum of one hundred Target Condition subjects will be enrolled. All studies will be completed on the day of enrollment.
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24014
About this study
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.
- Conditions
- Brain Injuries, Traumatic
- Being tested
- Head and Intraocular Trauma Tool, SCAT-5
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Head and Intraocular Trauma ToolDevice
Also called HITT 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.
SCAT-5Diagnostic test
Also called Sport Concussion Assessment Tool - 5th Edition
Participant is to complete Step 2 (Symptom Evaluation) and Step 3 (Cognitive Screening) of SCAT-5 test.
| Study group | Role | What they receive |
|---|---|---|
| TBI Patients | 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. Receives: Device: Head and Intraocular Trauma Tool; Diagnostic Test: SCAT-5 | |
| Controls | 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. Receives: Device: Head and Intraocular Trauma Tool; Diagnostic Test: SCAT-5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (1)
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.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start1 Dec 2021
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Injuries, TraumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rebiscan, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Carilion Clinic
- Responsible party
- Sponsor
- Investigators
- Damon R Kuehl, MD, Principal investigator, Carilion Roanoke Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05092295
- Sponsor's protocol ID
- 002_Q201535
- Status last verified
- Aug 2026
- First submitted
- 22 Oct 2021
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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 Carilion Roanoke Memorial Hospital.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Head and Intraocular Trauma Tool for the Identification of Mild Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT05092295
- Acronym / sponsor ID
- 002_Q201535
- Conditions
- Brain Injuries, Traumatic
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Rebiscan, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Carilion Clinic
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 25 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TBI Patients | – | Device: Head and Intraocular Trauma Tool, Diagnostic Test: SCAT-5TBI 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. |
| Controls | – | Device: Head and Intraocular Trauma Tool, Diagnostic Test: SCAT-5Participants 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. |
Who may qualify
- Ages
- 13 to 45 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Target participants for the study population include those within 2 weeks of blunt head trauma, with a Glasgow Coma Scale score of greater than or equal to thirteen. A minimum of one hundred Target Condition subjects will be enrolled. All studies will be completed on the day of enrollment.
Key inclusion criteria (6 listed)
- Age 13-45 years
- Presents to the facility within 2 weeks of head trauma
- Able to provide informed consent
- Able to participate in the examination, including the ability to follow simple instructions
- Fluency in English or Spanish
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Head and Intraocular Trauma ToolAlso: HITT deviceHITT 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. | Device | Controls, TBI Patients |
| SCAT-5Also: Sport Concussion Assessment Tool - 5th EditionParticipant is to complete Step 2 (Symptom Evaluation) and Step 3 (Cognitive Screening) of SCAT-5 test. | Diagnostic test | Controls, TBI Patients |
Primary outcome
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.
1 secondary outcome
TBI Monitor
Time frame: 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: 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 Carilion Roanoke Memorial Hospital.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Damon R Kuehl, MD principal investigator
Carilion Roanoke Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injuries, Traumatic, run by Rebiscan, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TBI Detection (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.