Traumatic Brain Injury (TBI) PatientsNCT02030366
Chromatic Multifocal Pupillometer for Detection and Follow-up of Acute Head Injury
An observational study of Traumatic Brain Injury (TBI) Patients, run by Sheba Medical Center at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury (TBI) Patients
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Oct 2015to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: TBI patients addmitted to Tel Hashomer Intensive Care Unit, and halthy volunteers.
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Neurosurgery Department, Sheba Medical Center
Tel HaShomer, 52621
Jacob Zauberman, MD, 97235302440, Jacob.Zauberman@sheba.health.gov.il
Lori Gueta, 97235308132, Lori.Gueta@sheba.health.gov.il
About this study
Official title: 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.
Read the 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:
- 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) Data will be recorded and analyzed.
- Conditions
- Traumatic Brain Injury (TBI) Patients
- 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.
| Study group | Role | What they receive |
|---|---|---|
| TBI patients | Not described | |
| Healthy Volunteers | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 7 days
Secondary outcomes (1)
Intra Cranial Pressure
TBI patients only will be continuously monitored for Intra Cranial Pressure (ICP)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study start1 Oct 2015
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Ygal Rotenstreich, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02030366
- Sponsor's protocol ID
- 9994-12-SMC
- Status last verified
- Apr 2024
- First submitted
- 6 Jan 2014
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 23482470
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Portable Chromatic Multifocal Pupillometer for Objective Early Detection and Follow-up of Changes in Intracranial Pressure in Patients With Acute Head Injury
- ClinicalTrials.gov ID
- NCT02030366
- Acronym / sponsor ID
- 9994-12-SMC
- Conditions
- Traumatic Brain Injury (TBI) Patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 Jan 2014 (estimated)
- 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.
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.
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:
- 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) Data will be recorded and analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TBI patients | – | – |
| Healthy Volunteers | – | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- TBI patients addmitted to Tel Hashomer Intensive Care Unit, and halthy volunteers.
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
1 secondary outcome
Intra Cranial Pressure
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Background: PubMed 23482470Skaat 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.
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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. This study is not recruiting at the moment.
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, 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 15 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 25 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jacob Zauberman, MD (97235302440, Jacob.Zauberman@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pupillary response at 5 points of Visual field to blue and red light (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02030366, which also lists 1 linked publication.
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 25 Apr 2024; AzTrials last refreshed its copy on 8 Nov 2026.