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

April 24, 2024 updated by: Dr. Ygal Rotenstreich, Sheba Medical Center

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Healthy Volunteers
TBI patients

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pupillary response at 5 points of Visual field to blue and red light
Time Frame: 7 days

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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Intra Cranial Pressure
Time Frame: 7 days
TBI patients only will be continuously monitored for Intra Cranial Pressure (ICP)
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sheba Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2015

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 6, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 8, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 9994-12-SMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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