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

NCT07474987 — Recruiting, 150 participants, Sheba Medical Center

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

Registry	NCT07474987
Status	Recruiting
Study type	Observational
Enrollment	150 (Estimated)
Sponsor	Sheba Medical Center (Other gov); collaborators: Reichman University
Conditions	Traumatic Brain Injury (TBI) Patients, Healthy Participants, Non-TBI Trauma
Interventions	Virtual Reality pupillometry test (Diagnostic test)
Dates	start 2026-04-01 (estimated), primary completion 2027-12-31 (estimated), completion 2027-12-31 (estimated), first posted 2026-03-16, last updated 2026-04-02
Locations	1 site in Israel

-Summary

Accurate and non-invasive methods for objectively identifying and monitoring head injuries (such as a concussion) are still an unmet need. It is known that pupil constriction in response to light stimuli can reflect changes in neural activity in the brain and is associated with sleep disturbances.

The investigators aim to examine the feasibility of using virtual reality goggles for monitoring traumatic brain injury by analyzing the pupillary response to multifocal chromatic stimuli. The VR device was programmed to present brief, low-intensity light stimuli (without glare), while the headset's camera records the pupil's reaction.

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+Detailed description

Healthy adults, patients with combat-related mild to moderate TBI and 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) will be recruited as non-TBI trauma (NTT) controls.

All subjects will undergo: A complete ophthalmologic examination to exclude ocular pathologies, including intraocular pressure (Goldmann applanation tonometry), and slit lamp biomicroscopy of the anterior and posterior segments; Assessment of best corrected visual acuity (BCVA); Color vision test, and VR Chromatic Pupilloperimetry (VRCP) testing.

+Arms and interventions

Arm	Type	Interventions	Description
TBI		Diagnostic Test: Virtual Reality pupillometry test
Healthy age- and gender-similar control		Diagnostic Test: Virtual Reality pupillometry test
Non-TBI trauma control		Diagnostic Test: Virtual Reality pupillometry test

Virtual Reality pupillometry test (Diagnostic test): A short (less than 10 minute) chromatic pupilloperimetry test administered via virtual reality (VR) goggles. Participants are exposed to brief, low-intensity chromatic light stimuli within the VR environment, designed to elicit pupillary responses without causing glare. Pupil size is monitored, enabling objective assessment of neural function and potential indicators of head trauma.

+Outcome measures

Primary outcomes

Pupil Light Reflex measured by the VR device [Baseline]: % pupil contraction
Pupil Light Reflex measured by the VR device [Baseline]: % recovery after each light stimulus

+Eligibility

Sex: All, ages: 18 Years to 67 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Sheba Medical Center	Tel Litwinsky, Tel Aviv (Gosh Dan)	Israel	Recruiting