Sheba Medical Center
Tel Litwinsky, Tel Aviv (Gosh Dan), 608552621, Israel
Location status: Recruiting
Location contact
Ifat Sher, PhD
CONTACT
Ygal Rotenstreich, MD
PRINCIPAL_INVESTIGATOR
CONTACT
NCT Number: NCT07474987
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.
Interested in participating?
Request Info18 year–67 year
All sexes
Observational
Tel Litwinsky, Tel Aviv (Gosh Dan), 608552621, Israel
Location status: Recruiting
Ifat Sher, PhD
CONTACT
Ygal Rotenstreich, MD
PRINCIPAL_INVESTIGATOR
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
TBI group:
Non-TBI Trauma group:
Exclusion criteria
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.
Time frame: Baseline
% pupil contraction
Time frame: Baseline
% recovery after each light stimulus
Contact information is provided by the study sponsor or research team.
Sheba Medical Center
Other Gov
Development of a Portable VR-based Chromatic Pupilloperimeter for Diagnosis and Monitoring of Traumatic Brain Injury
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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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