NCT07474987 Portable VR-based Chromatic Pupilloperimeter for Diagnosis and Monitoring of Traumatic Brain Injury
| NCT ID | NCT07474987 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sheba Medical Center |
| Condition | Traumatic Brain Injury (TBI) Patients |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2026-04-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2026-04-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07474987 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 67 Years, studying Traumatic Brain Injury (TBI) Patients. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07474987 currently recruiting?
Yes, NCT07474987 is actively recruiting participants. Contact the research team at Lori.Gueta@sheba.health.gov.il for enrollment information.
Where is the NCT07474987 trial being conducted?
This trial is being conducted at Tel Litwinsky, Israel.
Who is sponsoring the NCT07474987 clinical trial?
NCT07474987 is sponsored by Sheba Medical Center. The trial plans to enroll 150 participants.