Clinical trial Recruiting at 1 site Observational Ages 18 to 67

Using a portable VR headset to measure pupil reactions for diagnosing and monitoring head injury

Official title: Development of a Portable VR-based Chromatic Pupilloperimeter for Diagnosis and Monitoring of Traumatic Brain Injury

Run by Sheba Medical Center · NCT07474987 · Data updated 2026-11-12

This research tests whether a VR headset that flashes brief, gentle colored lights can detect and track traumatic brain injury by measuring how the pupil responds in people with TBI, similar non-TBI trauma patients, and healthy adults.

Quick facts

Study typeObservational
Ages18 Years to 67 Years
SexAll
Enrollment150 (estimated)
SponsorSheba Medical Center
Government
Locations1 site (Tel HaShomer, Tel Aviv (Gosh Dan))
StatusRecruiting
StartedApril 1, 2026
Main results expectedDecember 31, 2027
Study endsDecember 31, 2027
Registry record updatedApril 2, 2026
Trial IDNCT07474987 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults with combat-related mild to moderate TBI who have elevated GFAP/UCHL1 blood biomarkers or acute CT findings, plus age- and gender-matched non-TBI injured soldiers and healthy volunteers for comparison.

Probably not a fit

People with active ocular disease, recent eye surgery, or preexisting neuropsychiatric or neurodegenerative conditions are excluded and would not be expected to benefit from this test.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study uses a portable virtual reality headset programmed to present brief, low-intensity chromatic light stimuli while the built-in camera records pupillary responses. Participants include combat-related mild to moderate TBI patients, age- and gender-matched soldiers with non-TBI trauma, and healthy adults. All participants undergo a full eye exam (including intraocular pressure, slit-lamp exam, visual acuity, and color vision) and VR Chromatic Pupilloperimetry testing, and TBI cases are characterized by positive blood biomarkers (GFAP/UCHL1) and/or acute head CT findings. The design is observational and compares pupil response patterns across groups to see if the VR pupillometry signatures correspond with TBI presence and severity.

Why it matters

Potential benefit: If successful, this could offer a quick, noninvasive, objective tool to help detect and monitor traumatic brain injury using pupil measurements.

How similar studies have gone: Prior pupillometry studies have shown promise for detecting TBI-related changes, but using a portable VR-based chromatic pupilloperimeter is a newer approach with limited prior validation.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Male and female subjects
2. Clear ocular media a

TBI group:

1. Combat-related mild to moderate TBI
2. Have either elevated TBI-associated blood biomarkers (Abbott Allinity I, GFAP/ UCHL1) and/or initial trauma head CT positive for acute intracranial trauma

Non-TBI Trauma group:

1\. Age- and gender-similar soldiers without TBI (defined as war-related injury who screen negative for TBI based on symptoms, blood, and/or head CT)

Exclusion Criteria:

1. Neuropsychiatric diseases
2. Any other neurodegenerative diseases
3. History of stroke, epilepsy, head trauma, or head tumors
4. Ocular disease or ocular surgery within the last six months

Where it's running

  • Sheba Medical Center
    Tel HaShomer, Tel Aviv (Gosh Dan), Israel
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.