Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2026-01-01 @ 5:37 PM
Study NCT ID:
NCT05092295
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-04
First Post:
2021-10-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Head and Intraocular Trauma Tool for the Identification of Mild Traumatic Brain 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': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-02', 'studyFirstSubmitDate': '2021-10-22', 'studyFirstSubmitQcDate': '2021-10-22', 'lastUpdatePostDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TBI Detection', 'timeFrame': '1 day', 'description': 'Patients who have diagnosed TBI and are admitted to the hospital for treatment will have their eyes scanned to identify whether the HITT device can accurately identify patients with TBI.'}], 'secondaryOutcomes': [{'measure': 'TBI Monitor', 'timeFrame': '14 days', 'description': 'Patients who have remained in the hospital for TBI and received initial HITT device scan will receive a second set of scans at 2 weeks to identify whether the HITT device can accurately identify patients with TBI.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Brain Injuries, Traumatic']}, 'descriptionModule': {'briefSummary': 'Rebion has developed a device, the Rebion trauma tool (referred to as the head and intraocular trauma tool, or "HITT"), that detects ocular fixation and alignment using a binocular retinal scan. Preliminary data obtained from hospitalized patients with a clinically-confirmed traumatic brain injury (TBI) and uninjured controls indicates that the device can detect changes in ocular fixation, alignment, and saccades that are related to brain injury. This study seeks to evaluate the ability of the Rebion trauma tool to assess perturbations in eye movements resulting from TBI. The study will enroll 100 TBI patients and 100 controls.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '13 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Target participants for the study population include those within 2 weeks of blunt head trauma, with a Glasgow Coma Scale score of greater than or equal to thirteen. A minimum of one hundred Target Condition subjects will be enrolled. All studies will be completed on the day of enrollment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 13-45 years\n2. Presents to the facility within 2 weeks of head trauma\n3. Able to provide informed consent\n\n • If minor, then able to provide parental consent and minor assent\n4. Able to participate in the examination, including the ability to follow simple instructions\n5. Fluency in English or Spanish\n\nExclusion Criteria:\n\n1. Glasgow Coma Scale score of equal to or less than 13 at the time of study enrollment\n2. Under the influence of alcohol or drugs\n3. Previous eye surgery\n4. Visual acuity known to be 20/200 or less in either eye\n5. Known strabismus, amblyopia (lazy eye), or double vision\n6. Known eye movement disorder, including nystagmus\n7. Known optic nerve disease, including papilledema or optic neuropathy\n8. Known retinal disease, including macular degeneration or retinal degeneration\n9. Known cataract\n10. History of neurosurgery\n11. History of stroke/brain hemorrhage, brain tumor, or epilepsy\n12. Any head trauma requiring medical attention from a physician within the last 6 months\n13. Diagnosed dementia or cognitive impairment requiring assistance for daily living\n14. Other condition(s) under the care of a neurologist\n15. Psychiatric hospitalization in the last 90 days\n16. Subject considered unsuitable for participation in this clinical trial by PI, treating clinician, or study research staff\n17. Any minor brain injury regardless of loss of consciousness'}, 'identificationModule': {'nctId': 'NCT05092295', 'briefTitle': 'Head and Intraocular Trauma Tool for the Identification of Mild Traumatic Brain Injury', 'organization': {'class': 'INDUSTRY', 'fullName': 'Rebiscan, Inc.'}, 'officialTitle': 'Head and Intraocular Trauma Tool for the Identification of Mild Traumatic Brain Injury', 'orgStudyIdInfo': {'id': '002_Q201535'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TBI Patients', 'description': 'TBI participants 13 to 45 years of age, recruited from patients at a clinical research facility who present with head trauma. Clinical evaluation for the patient can be positive (target condition present) or negative (target condition absent) for mTBI. Enrollment is to occur within 2 weeks of the incident injury.', 'interventionNames': ['Device: Head and Intraocular Trauma Tool', 'Diagnostic Test: SCAT-5']}, {'label': 'Controls', 'description': 'Participants should not be part of the Intended Use Population. Subjects that present to the hospital, clinic or emergency department, either as a patient or non-patient, with no history of head trauma.', 'interventionNames': ['Device: Head and Intraocular Trauma Tool', 'Diagnostic Test: SCAT-5']}], 'interventions': [{'name': 'Head and Intraocular Trauma Tool', 'type': 'DEVICE', 'otherNames': ['HITT device'], 'description': 'HITT device to scan eyes of participants up to 3 times (\\~45 seconds each) at time of admittance to study. Participant is to place chin in chin-rest and fixate on illuminated light on device.', 'armGroupLabels': ['Controls', 'TBI Patients']}, {'name': 'SCAT-5', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Sport Concussion Assessment Tool - 5th Edition'], 'description': 'Participant is to complete Step 2 (Symptom Evaluation) and Step 3 (Cognitive Screening) of SCAT-5 test.', 'armGroupLabels': ['Controls', 'TBI Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24014', 'city': 'Roanoke', 'state': 'Virginia', 'country': 'United States', 'facility': 'Carilion Roanoke Memorial Hospital', 'geoPoint': {'lat': 37.27097, 'lon': -79.94143}}], 'overallOfficials': [{'name': 'Damon R Kuehl, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Carilion Roanoke Memorial Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'timeFrame': 'Data will be shared on an ongoing basis, and cumulatively at the end of the study. Study length is expected to be 2 months from the first enrolled participant.', 'ipdSharing': 'YES', 'description': 'Aggregate data and individual test reports will be made available to the HITT device manufacturer to better understand its performance at identifying TBI. Personal identifiable data will not be shared with anyone outside of the Carilion Roanoke Memorial Hospital.', 'accessCriteria': 'Data will only be shared with researchers involved in the study at the Carilion Roanoke Memorial Hospital, and only trained staff members at the device manufacturer.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rebiscan, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Carilion Clinic', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}