Actively Recruiting

Age: 18Years - 67Years
All Genders
Healthy Volunteers
ID07474987

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

Age: 18Years - 67Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

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)

Long-term Monitoring

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

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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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Frequently Asked Questions

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