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

ConditionsTraumatic Brain Injury (TBI) Patients Healthy Participants Non-TBI Trauma

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-67

SponsorSheba Medical Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Male and female subjects

Clear ocular media a

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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.

Treatment groups

150 Participants

are divided into 3 treatment groups

Group A: TBI1 intervention

Group B: Healthy age- and gender-similar control1 intervention

Group C: Non-TBI trauma control1 intervention

Trial outcomes

Primary outcomes

Pupil Light Reflex measured by the VR device

% pupil contraction

Time frame

Baseline

Pupil Light Reflex measured by the VR device

% recovery after each light stimulus

Time frame

Baseline

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sheba Medical Center

Lead sponsor

Reichman University

Collaborator

Source ClinicalTrials.gov

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