RECRUITINGOBSERVATIONAL

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form 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 willing to sign a consent form to participate in the study, signed by a family member and independent physician. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Locations (1)

Neurosurgery Department, Sheba Medical Center

Tel Litwinsky, Israel