Traumatic Brain Injury Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 67
Healthy Volunteers: t
View:

• 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)

Locations
Other Locations
Israel
Sheba Medical Center
RECRUITING
Tel Litwinsky
Contact Information
Primary
Lori Gueta
Lori.Gueta@sheba.health.gov.il
+972527485888
Time Frame
Start Date: 2026-04-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 150
Treatments
TBI
Healthy age- and gender-similar control
Non-TBI trauma control
Related Therapeutic Areas
Sponsors
Collaborators: Reichman University
Leads: Sheba Medical Center

This content was sourced from clinicaltrials.gov