[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100527028":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":10,"centralContacts":10,"locations":26,"responsibleParty":51,"collaborators":53,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":10,"eligibilityCriteria":63,"healthyVolunteers":64,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":10,"studyType":71,"phases":10,"briefSummary":72,"conditions":73,"keywords":10,"overallStatus":29,"whyStopped":10,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Rebiscan, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Controls",null,"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 and, are 18-45 years of age.",[13],"Device: Head and Intraocular Trauma Tool",{"label":15,"type":10,"description":16,"interventionNames":17},"TBI-Suspected Patients","TBI participants 18-45 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. Testing will occur on Day-0, Day-14, and Day-30.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","Head and Intraocular Trauma Tool","HITT device to scan the eyes of participants up to 3 times (\\~45 seconds each) at the time of admittance to study. The participant is to place the chin in the chin-rest and fixate on the illuminated light on the device.",[9,15],[25],"HITT",[27],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Boston Medical Center Concussion Clinic, Ryan Center for Sports Medicine & Rehabilitation at Boston University","RECRUITING","Boston","Massachusetts","02215","United States","US",{"type":36,"coordinates":37},"Point",[38,39],-71.05977,42.35843,{"lat":39,"lon":38},[42,47],{"name":43,"role":44,"phone":45,"phoneExt":10,"email":46},"Nathan Cardoos, MD","CONTACT","617-414-6800","ncardoos@bu.edu",{"name":48,"role":44,"phone":49,"phoneExt":10,"email":50},"Justin Shaka, MBA","857-600-0982","jgshaka@rebion.net",{"type":52,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[54],{"name":55,"class":56},"Boston Medical Center","OTHER","100527028","mtbi-identification-and-monitoring-through-retinal-scanning-100527028",false,"NCT06142435","mTBI Identification and Monitoring Through Retinal Scanning","Mild Traumatic Brain Injury Identification and Monitoring Through Retional Scanning","Inclusion Criteria:\n\n1. Age 18-45 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 consent\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 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\u002F200 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\u002Fbrain 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",true,"ALL","18 Years","45 Years",{"count":69,"type":70},60,"ESTIMATED","OBSERVATIONAL","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 60 TBI patients and 20 controls.",[74],"Brain Injuries, Traumatic","2026-05-18",{"date":77,"type":78},"2026-05-20","ACTUAL",{"date":80,"type":78},"2023-08-15",{"date":82,"type":70},"2026-08-31",{"name":5,"class":6},1]