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NCT Number: NCT07474987

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.

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Key information

Age range

18 year–67 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sheba Medical Center

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

Location status: Recruiting

Location contact

Ifat Sher, PhD

CONTACT

[email protected]

+972527485888

Ygal Rotenstreich, MD

PRINCIPAL_INVESTIGATOR

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Pupil Light Reflex measured by the VR device

    Time frame: Baseline

    % pupil contraction

  2. Pupil Light Reflex measured by the VR device

    Time frame: Baseline

    % recovery after each light stimulus

Study contacts

Contact information is provided by the study sponsor or research team.

Lori Gueta

CONTACT

[email protected]

+972527485888

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Collaborators

  • Reichman University

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 16, 2026
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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