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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07474987
Enrollment
150
Registered
2026-03-16
Start date
2026-04-01
Completion date
2027-12-31
Last updated
2026-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Participants, Non-TBI Trauma, Traumatic Brain Injury (TBI) Patients

Brief 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.

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.

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.

Sponsors

Sheba Medical Center
Lead SponsorOTHER_GOV
Reichman University
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 67 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Pupil Light Reflex measured by the VR deviceBaseline% pupil contraction

Countries

Israel

Contacts

CONTACTLori Gueta
Lori.Gueta@sheba.health.gov.il+972527485888

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026