Chromatic Multifocal Pupillometer for Detection and Follow-up of Acute Head Injury

A Portable Chromatic Multifocal Pupillometer for Objective Early Detection and Follow-up of Changes in Intracranial Pressure in Patients With Acute Head Injury

Traumatic Brain Injury (TBI) is a common injury in combat, terrorist attacks and sports such as football and hockey. Unnecessary delays in the diagnosis and treatment of brain damage in patients who can benefit from evacuation procedures can lead to worse brain injury, worse outcome and, sometimes, unnecessary death. However, there is no reliable and sensitive method for diagnosis of TBI severity in the field. In this study we will examine the feasibility of using this a multifocal chromatic pupillometer for monitoring TBI, by examining the pupillary response to multifocal chromatic stimuli in intracranial pressure (ICP)-monitored severe TBI patients. As control, normal subjects will be tested for pupillary responses using this device.

Study Overview

• Status: Recruiting
• Conditions: Traumatic Brain Injury (TBI) Patients

Detailed Description

To examine the feasibility of using the multifocal chromatic pupillometer for monitoring TBI, the pupillary response to multifocal chromatic stimuli will be assessed in 20 healthy subjects and 20 ICP-monitored severe TBI patients.

The portable pupillometer will be tested in 20 healthy volunteers. Their pupillary responses will be measured 3 times/day for 1 week.

Pupillary response of 20 severe TBI patients will be evaluated as detailed below at the following time points:

1. At admittance to ICU, prior to insertion of ICP and CT scan
2. Prior to CT scans that are routinely performed at day 3 and 7 post injury
3. Routinely at the beginning of every medical personnel shift for 7 days (3 times a day).
4. With every change in ICP(more than 5 mmHg for more then 15 min) Data will be recorded and analyzed.

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

• Study Contact: Name: Jacob Zauberman, MD; Phone Number: 97235302440; Email: Jacob.Zauberman@sheba.health.gov.il
• Study Contact Backup: Name: Ygal Rotenstreich, MD; Phone Number: 97235302880; Email: Ygal.Rotenstreich@sheba.health.gov.il

Study Locations

• Israel
  • Tel Hashomer, Israel, 52621
    • Recruiting
    • Neurosurgery Department, Sheba Medical Center
    • Contact: Jacob Zauberman, MD; Phone Number: 97235302440; Email: Jacob.Zauberman@sheba.health.gov.il
    • Contact: Lori Gueta; Phone Number: 97235308132; Email: Lori.Gueta@sheba.health.gov.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

TBI patients addmitted to Tel Hashomer Intensive Care Unit, and halthy volunteers.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Healthy Volunteers
TBI patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pupillary response at 5 points of Visual field to blue and red light	Pupillary response at 5 points of Visual field to blue and red light will be measured 3 times a day for a week for the health subjects. The TBI patients will be monitored for pupillary response: At admittance to ICU, prior to insertion of ICP and CT scan; Prior to CT scans that are routinely performed at day 3 and 7 post injury; Routinely at the beginning of every medical personnel shift for 7 days (3 times a day).; With every change in ICP(more than 5 mmHg for more then 15 min)	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intra Cranial Pressure	TBI patients only will be continuously monitored for Intra Cranial Pressure (ICP)	7 days

Collaborators and Investigators

• Sponsor: Sheba Medical Center

Publications and helpful links

General Publications

• Skaat A, Sher I, Kolker A, Elyasiv S, Rosenfeld E, Mhajna M, Melamed S, Belkin M, Rotenstreich Y. Pupillometer-based objective chromatic perimetry in normal eyes and patients with retinal photoreceptor dystrophies. Invest Ophthalmol Vis Sci. 2013 Apr 17;54(4):2761-70. doi: 10.1167/iovs.12-11127.

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: January 6, 2014
• First Submitted That Met QC Criteria: January 6, 2014
• First Posted (Estimate): January 8, 2014

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 15, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Craniocerebral Trauma
• Other Study ID Numbers: 9994-12-SMC