RecruitingNCT07474987

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

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


Sponsor

Sheba Medical Center

Enrollment

150 participants

Start Date

Apr 1, 2026

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 67 Years

Inclusion Criteria7

  • Male and female subjects
  • Clear ocular media a
  • TBI group:
  • Combat-related mild to moderate TBI
  • 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:
  • \. 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 Criteria4

  • Neuropsychiatric diseases
  • Any other neurodegenerative diseases
  • History of stroke, epilepsy, head trauma, or head tumors
  • Ocular disease or ocular surgery within the last six months

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Interventions

DIAGNOSTIC_TESTVirtual Reality pupillometry 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.


Locations(1)

Sheba Medical Center

Tel Litwinsky, Tel Aviv (Gosh Dan), Israel

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NCT07474987


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