Traumatic Brain Injury (TBI) PatientsNCT07474987
Portable VR-based Chromatic Pupilloperimeter for Diagnosis and Monitoring of Traumatic Brain Injury
An observational study of Traumatic Brain Injury (TBI) Patients and Healthy Participants, run by Sheba Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury (TBI) Patients, Healthy Participants, Non-TBI Trauma
- What is being tested?
- Virtual Reality pupillometry test
- How many people
- 150 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Apr 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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:
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Tel HaShomer, Tel Aviv (Gosh Dan), 608552621
Ifat Sher, PhD, +972527485888, Ifat.SherRosenthal@sheba.health.gov.il
Ygal.Rotenstreich@sheba.health.gov.il
About this study
Official title: Development of a 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.
Read the detailed description
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.
- Being tested
- Virtual Reality pupillometry test
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality pupillometry testDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| TBI | Not described Receives: Diagnostic Test: Virtual Reality pupillometry test | |
| Healthy age- and gender-similar control | Not described Receives: Diagnostic Test: Virtual Reality pupillometry test | |
| Non-TBI trauma control | Not described Receives: Diagnostic Test: Virtual Reality pupillometry test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pupil Light Reflex measured by the VR device
% pupil contraction
Measured: Baseline
Pupil Light Reflex measured by the VR device
% recovery after each light stimulus
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain Injury (TBI) PatientsStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- Reichman University
- Responsible party
- Principal investigator, Dr. Ygal Rotenstreich, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07474987
- Sponsor's protocol ID
- 1376-24-SMC
- Status last verified
- Mar 2026
- First submitted
- 30 Sep 2025
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Portable VR-based Chromatic Pupilloperimeter for Diagnosis and Monitoring of Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT07474987
- Acronym / sponsor ID
- 1376-24-SMC
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- Reichman University
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality pupillometry testA 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. | Diagnostic test | Healthy age- and gender-similar control, Non-TBI trauma control, TBI |
Primary outcome
Pupil Light Reflex measured by the VR device
Time frame: Baseline
% pupil contraction
Pupil Light Reflex measured by the VR device
Time frame: Baseline
% recovery after each light stimulus
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury (TBI) Patients and Healthy Participants, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lori Gueta (+972527485888, Lori.Gueta@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pupil Light Reflex measured by the VR device (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.