TBI identification and monitoring through retinal scanning

通过视网膜扫描进行 TBI 识别和监测

• 批准号: 10009588
• 负责人: Shane Pixton
• 金额: $ 14.93万
• 依托单位: REBISCAN, LLC
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-05-01 至 2020-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10009588
• 关键词: Accident and Emergency department; Acute; Affect; Age; Algorithms; Bilateral; Binocular Vision; Birefringence; Brain; Brain Concussion; Cessation of life; Child; Childhood; Clinical; Clinical Protocols; Clinical Research; Craniocerebral Trauma; Data; Decision Making; Detection; Development; Devices; Diagnosis; Electronics; Emergency department visit; Engineering; Ensure; Environment; Epidemic; Eye; Goals; Grant; Hand; Head; Hospitalization; Impairment; Individual; Injury; Institutional Review Boards; Intervention; Lasers; Legal patent; Light; Measures; Medical; Methods; Modeling; Monitor; National Institute of Neurological Disorders and Stroke; Neurologic; Ocular Convergence; Optics; Outcome; Output; Participant; Patients; Performance; Peripheral; Pilot Projects; Primary Health Care; Provider; Recording of previous events; Recovery; Reporting; Research; Retina; Risk; Scanning; Signal Transduction; Small Business Innovation Research Grant; Speed; Structure; Symptoms; Technology; Testing; Time; Trauma; Traumatic Brain Injury; Traumatic injury; United States; Volition; base; brain dysfunction; chronic traumatic encephalopathy; design; disability; experience; fight against; gaze; graphical user interface; healing; improved; innovative technologies; insight; laptop; mild traumatic brain injury; neuropsychiatric disorder; neurotensin mimic 1; new technology; patient response; performance tests; persistent symptom; point of care; portability; prevent; prototype; research clinical testing; response; sample fixation; success; tool; treatment response; usability; visual tracking

Project Summary/Abstract TBI (traumatic brain injury) is the leading cause of long-term disability and death for individuals under the age of 45. Over 2.5 million cases of TBI are reported each year in the United States, with ~3-5 million individuals living with TBI-related disabilities. About 75% of patients diagnosed with TBI are classified as mTBI, which can be difficult to diagnose, as history is often incomplete and symptoms are nonspecific and overlap with a broad range of neuropsychiatric disorders. Although most patients with mTBI make a full recovery, as many as 20% do not. Individuals who experience multiple mTBI are at increased risk of persistent post-injury symptoms and long-term complications, including serious sequelae such as chronic traumatic encephalopathy (CTE). Simple interventions such as removing the patient from risky environments may prevent these complications by allowing time for the brain to heal and preventing further injury. Management of mTBI in the field, in the emergency department, and even in the primary care office is complicated by the absence of a safe, simple, and sensitive tool to assist in making the diagnosis and in tracking a patient's recovery. Rebion has produced a portable device – with compelling preliminary, pilot data – for identifying and monitoring traumatic brain injury in patients by way of a retinal scan. The device, which has FDA clearance (DEN 130051) for identifying misaligned eyes in children, has shown to accurately identify acute episodes of mild traumatic brain injury (mTBI) and track a patient's recovery that matches the medical diagnosis. The device is called HITT, the Head and Intraocular Trauma Test device. Grant support is being requested to support further development of the HITT device so that it can be field deployable in a larger-scale clinical study. The data that has been collected to date has led to a better understanding of the algorithm and electronics requirements that will be needed to make the HITT device usable –and interpretable– by a lay user. Successful execution of project milestones will lead to pivotal clinical studies that will be vetted by the FDA. Data from the studies will be submitted to the FDA for consideration of market clearance of the HITT device.

项目总结/摘要 TBI（创伤性脑损伤）是年龄以下个体长期残疾和死亡的主要原因。 为45.在美国，每年报告超过250万例TBI病例，约有3-5百万人 与TBI相关的残疾。大约75%的TBI患者被归类为mTBI， 很难诊断，因为病史往往不完整，症状是非特异性的，与广泛的症状重叠。 一系列神经精神疾病尽管大多数mTBI患者都能完全康复，但仍有多达20% 不要。经历多次mTBI的个体发生持续性损伤后症状的风险增加， 长期并发症，包括严重后遗症，如慢性创伤性脑病（CTE）。简单 诸如将患者从危险环境中移除的干预措施可以通过以下方式预防这些并发症： 让大脑有时间愈合并防止进一步的伤害。 在现场，急诊室，甚至在初级保健办公室管理mTBI， 由于缺乏一种安全、简单和灵敏的工具来帮助诊断， 追踪病人的康复情况 Rebion已经生产了一种便携式设备--具有令人信服的初步试验数据--用于识别和监测 外伤性脑损伤患者的视网膜扫描。该器械已获得FDA批准（DEN 130051） 用于识别儿童的眼睛错位，已经证明可以准确地识别轻度创伤的急性发作， 脑损伤（mTBI），并跟踪患者的恢复，匹配的医疗诊断。这种设备叫 HITT，头部和眼内创伤测试设备。 目前正在申请赠款支持，以支持进一步开发HITT装置， 可用于大规模临床研究。迄今为止收集的数据已经导致了一个更好的 了解制造HITT设备所需的算法和电子要求 可由外行用户使用和解释。 项目里程碑的成功执行将导致关键的临床研究，将由FDA审查。 研究数据将提交给FDA，以考虑HITT器械的上市许可。