Actively Recruiting
Development of a Portable VR-based Chromatic Pupilloperimeter for Diagnosis and Monitoring of Traumatic Brain Injury
Led by Sheba Medical Center · Updated on 2026-04-02
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Sheba Medical Center
Lead Sponsor
R
Reichman University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating new, accurate, and non-invasive ways to identify and monitor head injuries like concussions. This study looks at how pupil constriction, in response to light, reflects brain activity changes and is linked to sleep problems. The goal is to explore the use of virtual reality (VR) goggles to monitor traumatic brain injury (TBI) by analyzing how pupils react to colorful light patterns. Participants include healthy adults, patients with combat-related mild to moderate TBI, and age- and gender-matched soldiers without TBI who have suffered trauma. Each participant will undergo a full eye exam, including tests for eye pressure and structure, vision clarity, color vision, and a VR-based pupilloperimetry test. This test uses VR goggles that show brief, low-intensity colored light stimuli while the headset camera records pupil reactions without causing glare. During the study, participants will be assessed using the VR device to measure their pupil light reflex at baseline. The eye exams and VR tests help researchers objectively evaluate neural function and potential signs of head trauma. The study lasts from April 2026 until December 2027, and participants' pupil responses will be closely monitored to support diagnosis and tracking of TBI.
CONDITIONS
Brief Title
Portable VR-based Chromatic Pupilloperimeter for Diagnosis and Monitoring of Traumatic Brain Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female subjects
- Clear ocular media
- Combat-related mild to moderate traumatic brain injury for TBI group
- Elevated TBI-associated blood biomarkers and/or positive initial head CT for acute intracranial trauma for TBI group
- Age- and gender-similar soldiers without TBI but with trauma for Non-TBI Trauma group
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Less than 1 day
Participants undergo a complete ophthalmologic examination including intraocular pressure measurement, slit lamp biomicroscopy, visual acuity and color vision tests, and a Virtual Reality chromatic pupilloperimetry test to assess neural function related to head trauma.
1 visit (in-person)
Duration - Up to the study completion date
Participants are observed for ongoing assessment of pupil light reflex and neural function over time using the VR device.
Visit schedule not specified
Trial Site Locations
Total: 1 location
1
Sheba Medical Center
Tel Litwinsky, Tel Aviv (Gosh Dan), Israel, 608552621
Actively Recruiting
Research Team
L
Lori Gueta
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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