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

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

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 type: Observational
• Enrollment: 150 (estimated)
• Ages: 18 Years to 67 Years
• Sex: All
• Sponsor: Sheba Medical Center (Government)
• Locations: 1 site (Tel Litwinsky, Tel Aviv (Gosh Dan))
• Trial ID: NCT07474987 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Tel Litwinsky, Tel Aviv (Gosh Dan)

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

Study contacts

• Study coordinator: Lori Gueta

Conditions Traumatic Brain Injury Patients; Healthy Participants; Non-TBI Trauma