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

Recruitingn/aAges 18 Years - 67 YearsAllSheba Medical Center
NCT07474987 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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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📋 Eligibility rules (as published)
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
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What it tests

  • Virtual Reality pupillometry test
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Where

1 site
Sheba Medical Center
Tel Litwinsky, Israel
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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