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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Participants; Traumatic Brain Injury (TBI) Patients; Non-TBI Trauma
• Intervention / Treatment: Diagnostic test: Virtual Reality pupillometry test

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.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Lori Gueta; Phone Number: +972527485888; Email: Lori.Gueta@sheba.health.gov.il

Study Locations

• Israel
  • Tel Aviv (Gosh Dan)
    • Tel Litwinsky, Tel Aviv (Gosh Dan), Israel, 608552621
      • Recruiting
      • Sheba Medical Center
      • Contact: Ifat Sher, PhD; Phone Number: +972527485888; Email: Ifat.SherRosenthal@sheba.health.gov.il
      • Contact: Email: Ygal.Rotenstreich@sheba.health.gov.il
      • Principal Investigator: Ygal Rotenstreich, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

1. TBI group - soldiers with combat-related mild to moderate TBI (defined as blast TBI presenting Glasgow Coma Scale 13-15) and have either elevated TBI-associated blood biomarkers (Abbott Allinity I, GFAP/ UCHL1) and/or initial trauma head CT positive for acute intracranial trauma
2. Non-TBI trauma (NTT) group - 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) .
3. Healthy volunteers - Age- and gender-similar to TBU group.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TBI	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.
Healthy age- and gender-similar control	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.
Non-TBI trauma control	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pupil Light Reflex measured by the VR device	% pupil contraction	Baseline
Pupil Light Reflex measured by the VR device	% recovery after each light stimulus	Baseline

Collaborators and Investigators

• Sponsor: Sheba Medical Center
• Collaborators: Reichman University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: September 30, 2025
• First Submitted That Met QC Criteria: March 14, 2026
• First Posted (Actual): March 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 28, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: 1376-24-SMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No