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

NCT02030366 | Recruiting

• 1 other identifier: 9994-12-SMC
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Traumatic Brain Injury (TBI) Patients

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Intra Cranial Pressure

  7 days

Study Arms (2)

TBI patients

Healthy Volunteers

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Neurosurgery Department, Sheba Medical Center

Tel Litwinsky, 52621, Israel

RECRUITING

Related Publications (1)

• 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.

  PMID: 23482470 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Jacob Zauberman, MD

CONTACT

97235302440; Jacob.Zauberman@sheba.health.gov.il

Ygal Rotenstreich, MD

CONTACT

97235302880; ygal.rotenstreich@sheba.health.gov.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Electrophysiology Service

Study Record Dates

• First Submitted: January 6, 2014
• First Posted: January 8, 2014
• Study Start: October 1, 2015
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 25, 2024

Record last verified: 2024-04

Locations

IL (1)