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Clinical Trials in Israel / NCT07474987
Recruiting Observational

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

NCT07474987 · tracked via the Priya Life Science Israel tracker
Phase
Observational
Started
2026-04-01
Last updated
2026-04-02

Condition(s) studied

Traumatic Brain Injury (TBI) PatientsHealthy ParticipantsNon-TBI Trauma

Investigational drug(s) / intervention(s)

Virtual Reality pupillometry test

Virtual 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.

Study 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

Sex
ALL
Min age
18 Years
Max age
67 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Sheba Medical Center Tel Litwinsky Tel Aviv (Gosh Dan) Recruiting

More Sheba Medical Center trials in Israel

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07474987 on ClinicalTrials.gov ↗ ← All trials in Israel