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

NCT ID: NCT02030366

Last Updated: 2024-04-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-10-01
• Study Completion Date: 2025-12-31

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.

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.

Conditions

Traumatic Brain Injury (TBI) Patients

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

TBI patients

No interventions assigned to this group

Healthy Volunteers

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr. Ygal Rotenstreich

Head of Electrophysiology Service

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Neurosurgery Department, Sheba Medical Center

Tel Litwinsky, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Jacob Zauberman, MD

Role: CONTACT

Jacob.Zauberman@sheba.health.gov.il

97235302440

Ygal Rotenstreich, MD

Role: CONTACT

ygal.rotenstreich@sheba.health.gov.il

97235302880

Facility Contacts

Jacob Zauberman, MD

Role: primary

Jacob.Zauberman@sheba.health.gov.il

97235302440

Lori Gueta

Role: backup

Lori.Gueta@sheba.health.gov.il

97235308132

References

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.

Reference Type: BACKGROUND

PMID: 23482470 (View on PubMed)

Other Identifiers

9994-12-SMC

Identifier Type: -

Identifier Source: org_study_id