Portable VR-based Chromatic Pupilloperimeter for Diagnosis and Monitoring of Traumatic Brain Injury

NCT07474987 | Recruiting

• 1 other identifier: 1376-24-SMC
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

TBI

Diagnostic Test: Virtual Reality pupillometry test

Healthy age- and gender-similar control

Diagnostic Test: Virtual Reality pupillometry test

Non-TBI trauma control

Diagnostic Test: Virtual Reality pupillometry test

Interventions

Virtual Reality pupillometry test DIAGNOSTIC_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; Non-TBI trauma control; TBI

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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:
• \. 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheba Medical Center: lead
• Reichman University: collaborator

Study Sites (1)

Sheba Medical Center

Tel Litwinsky, Tel Aviv (Gosh Dan), 608552621, Israel

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Lori Gueta

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Electrophysiology Clinic , Goldschleger Eye Institute, Sheba Medical Center

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: March 16, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 2, 2026

Record last verified: 2026-03

Locations

IL (1)