Portable VR-based Chromatic Pupilloperimeter for Diagnosis and Monitoring of Traumatic Brain Injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Virtual Reality pupillometry test.
- Who it may be relevant to
- Registry conditions: Traumatic Brain Injury (TBI) Patients, Healthy Participants, Non-TBI Trauma. Basic parameters: 18 years — 67 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Development of a Portable VR-based Chromatic Pupilloperimeter for Diagnosis and Monitoring of Traumatic Brain Injury
Overview
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 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.
Primary outcome measures
- Pupil Light Reflex measured by the VR device [Time frame: Baseline]
- Pupil Light Reflex measured by the VR device [Time frame: Baseline]
Eligibility criteria
Inclusion criteria
- 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:
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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Israel · 1 center
- Sheba Medical Center — Tel Litwinsky
Identifiers
NCT: NCT07474987 · 1376-24-SMC