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Clinical Trial NCT02030366 for Traumatic Brain Injury (TBI) Patients is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Sheba Medical CenterChromatic Multifocal Pupillometer for Detection and Follow-up of Acute Head Injury 40
Clinical Trial NCT02030366 is an observational study for Traumatic Brain Injury (TBI) Patients that is recruiting. It started on October 1, 2015 with plans to enroll 40 participants. Led by Sheba Medical Center, it is expected to complete by December 31, 2025. The latest data from ClinicalTrials.gov was last updated on April 25, 2024.
Brief 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. However, there is no reliable and sensitive method for diagnosis of TBI severity in the field. In thi...Show More
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 ...
Show MoreOfficial Title
A Portable Chromatic Multifocal Pupillometer for Objective Early Detection and Follow-up of Changes in Intracranial Pressure in Patients With Acute Head Injury
Conditions
Traumatic Brain Injury (TBI) PatientsPublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- 9994-12-SMC
NCT ID Number
Start Date (Actual)
2015-10-01
Last Update Posted
2024-04-25
Completion Date (Estimated)
2025-12-31
Enrollment (Estimated)
40
Study Type
Observational
Status
Recruiting
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
TBI patients | N/A |
Healthy Volunteers | N/A |
Primary Outcome Measures
Secondary 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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Intra Cranial Pressure | TBI patients only will be continuously monitored for Intra Cranial Pressure (ICP) | 7 days |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
- 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.
- 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.
Sheba Medical Center74 active studies to exploreStudy Responsible Party
Dr. Ygal Rotenstreich, Principal Investigator, Head of Electrophysiology Service, Sheba Medical Center
Study Central Contact
Contact: Jacob Zauberman, MD, 97235302440, [email protected]
Contact: Ygal Rotenstreich, MD, 97235302880, [email protected]
1 Study Locations in 1 Countries
Neurosurgery Department, Sheba Medical Center, Tel Litwinsky, 52621, Israel
Jacob Zauberman, MD, Contact, 97235302440, [email protected]
Lori Gueta, Contact, 97235308132, [email protected]
Recruiting