Using a pupillometer to monitor brain injury severity
A Portable Chromatic Multifocal Pupillometer for Objective Early Detection and Follow-up of Changes in Intracranial Pressure in Patients With Acute Head Injury
This study is testing a new device that measures how the pupils react to light in people with severe brain injuries and healthy individuals to see if it can help doctors understand the severity of the injury better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Sheba Medical Center Government |
| Locations | 1 site (Tel Hashomer) |
| Trial ID | NCT02030366 on ClinicalTrials.gov |
What this trial studies
This study examines the feasibility of a multifocal chromatic pupillometer to assess pupillary responses in patients with traumatic brain injury (TBI) and healthy subjects. The pupillometer will measure the pupillary response to chromatic stimuli in 20 severe TBI patients monitored for intracranial pressure (ICP) and 20 healthy volunteers. Measurements will be taken multiple times over a week, including at key clinical time points and in response to changes in ICP. The goal is to establish a reliable method for diagnosing TBI severity in real-time.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 70 with a confirmed diagnosis of severe TBI and indications for ICP monitoring.
Not a fit: Patients with mild TBI or those outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to quicker and more accurate assessments of TBI severity, potentially improving patient outcomes.
How similar studies have performed: While the use of pupillometers in TBI assessment is emerging, this specific approach is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Healthy subjects - * Male or female patients, age between 18 and 70 years, inclusive * Informed written consent will be obtained from all participants. * Normal eye examination * Best-corrected visual acuity (BCVA) of 20/20 * Normal color vision test (Roth-28-hue test) * Written informed consent to participate in the study, * TBI-patients: * Male or female patients, age between 18 and 70 years, inclusive * Initiation of study before the insertion of the ICP monitor. * TBI diagnosed by history and clinical examination * Glasgow Coma Scale (GCS) score between 3 and 8, inclusive * Evidence of TBI confirmed by abnormalities consistent with trauma on CT scan upon admission (diffuse injury II-IV, evacuated and non-evacuated mass lesion, Marshall's CT Classification) * Indication for ICP monitoring * Written informed consent to participate in the study, signed by a family member and independent physician. Exclusion Criteria: * Healthy subjects * History of past or present ocular disease * Use of any topical or systemic medications that could adversely influence efferent pupil movements * TBI-patients * High levels of barbiturate medications as they abolish pupillary responsiveness * Coma suspected to be primarily due to other causes (e.g. alcohol) * Preexisting clinically significant disease or chronic condition that can be ascertained at the time of admission and could affect pupillary response or measurement (such as known retinal dystrophy disease, glaucoma or dense cataract.
Where this trial is running
Tel Hashomer
- Neurosurgery Department, Sheba Medical Center — Tel Hashomer, Israel (Recruiting)
Study contacts
- Study coordinator: Jacob Zauberman, MD
- Email: Jacob.Zauberman@sheba.health.gov.il
- Phone: 97235302440
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.