Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2026-01-27 @ 5:41 PM
Study NCT ID:
NCT02030366
Status:
RECRUITING
Last Update Posted:
2024-04-25
First Post:
2014-01-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chromatic Multifocal Pupillometer for Detection and Follow-up of Acute Head Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-24', 'studyFirstSubmitDate': '2014-01-06', 'studyFirstSubmitQcDate': '2014-01-06', 'lastUpdatePostDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pupillary response at 5 points of Visual field to blue and red light', 'timeFrame': '7 days', 'description': '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:\n\n* At admittance to ICU, prior to insertion of ICP and CT scan\n* Prior to CT scans that are routinely performed at day 3 and 7 post injury\n* Routinely at the beginning of every medical personnel shift for 7 days (3 times a day).\n* With every change in ICP(more than 5 mmHg for more then 15 min)'}], 'secondaryOutcomes': [{'measure': 'Intra Cranial Pressure', 'timeFrame': '7 days', 'description': 'TBI patients only will be continuously monitored for Intra Cranial Pressure (ICP)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Traumatic Brain Injury (TBI) Patients']}, 'referencesModule': {'references': [{'pmid': '23482470', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe portable pupillometer will be tested in 20 healthy volunteers. Their pupillary responses will be measured 3 times/day for 1 week.\n\nPupillary response of 20 severe TBI patients will be evaluated as detailed below at the following time points:\n\n1. At admittance to ICU, prior to insertion of ICP and CT scan\n2. Prior to CT scans that are routinely performed at day 3 and 7 post injury\n3. Routinely at the beginning of every medical personnel shift for 7 days (3 times a day).\n4. With every change in ICP(more than 5 mmHg for more then 15 min) Data will be recorded and analyzed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'TBI patients addmitted to Tel Hashomer Intensive Care Unit, and halthy volunteers.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy subjects -\n* Male or female patients, age between 18 and 70 years, inclusive\n* Informed written consent will be obtained from all participants.\n* Normal eye examination\n* Best-corrected visual acuity (BCVA) of 20/20\n* Normal color vision test (Roth-28-hue test)\n* Written informed consent to participate in the study,\n* TBI-patients:\n* Male or female patients, age between 18 and 70 years, inclusive\n* Initiation of study before the insertion of the ICP monitor.\n* TBI diagnosed by history and clinical examination\n* Glasgow Coma Scale (GCS) score between 3 and 8, inclusive\n* 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)\n* Indication for ICP monitoring\n* Written informed consent to participate in the study, signed by a family member and independent physician.\n\nExclusion Criteria:\n\n* Healthy subjects\n* History of past or present ocular disease\n* Use of any topical or systemic medications that could adversely influence efferent pupil movements\n* TBI-patients\n* High levels of barbiturate medications as they abolish pupillary responsiveness\n* Coma suspected to be primarily due to other causes (e.g. alcohol)\n* 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."}, 'identificationModule': {'nctId': 'NCT02030366', 'briefTitle': 'Chromatic Multifocal Pupillometer for Detection and Follow-up of Acute Head Injury', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'A Portable Chromatic Multifocal Pupillometer for Objective Early Detection and Follow-up of Changes in Intracranial Pressure in Patients With Acute Head Injury', 'orgStudyIdInfo': {'id': '9994-12-SMC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TBI patients'}, {'label': 'Healthy Volunteers'}]}, 'contactsLocationsModule': {'locations': [{'zip': '52621', 'city': 'Tel Litwinsky', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Jacob Zauberman, MD', 'role': 'CONTACT', 'email': 'Jacob.Zauberman@sheba.health.gov.il', 'phone': '97235302440'}, {'name': 'Lori Gueta', 'role': 'CONTACT', 'email': 'Lori.Gueta@sheba.health.gov.il', 'phone': '97235308132'}], 'facility': 'Neurosurgery Department, Sheba Medical Center', 'geoPoint': {'lat': 32.05096, 'lon': 34.84588}}], 'centralContacts': [{'name': 'Jacob Zauberman, MD', 'role': 'CONTACT', 'email': 'Jacob.Zauberman@sheba.health.gov.il', 'phone': '97235302440'}, {'name': 'Ygal Rotenstreich, MD', 'role': 'CONTACT', 'email': 'ygal.rotenstreich@sheba.health.gov.il', 'phone': '97235302880'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Electrophysiology Service', 'investigatorFullName': 'Dr. Ygal Rotenstreich', 'investigatorAffiliation': 'Sheba Medical Center'}}}}