TBI identification and monitoring through retinal scanning

项目摘要/摘要 创伤性脑损伤是导致未成年人长期残疾和死亡的主要原因。 45岁。美国每年报告的脑损伤病例超过250万例，约有300-500万人 患有与脑外伤相关的残疾。大约75%的被诊断为脑损伤的患者被归类为脑损伤，这可以 很难诊断，因为病史往往不完整，症状没有特异性，与广泛的 一系列神经精神障碍。尽管大多数mTBI患者完全康复，但多达20%的患者 不要这样做。经历多处创伤性脑损伤的个体有更高的持续损伤后症状和 长期并发症，包括严重后遗症，如慢性创伤性脑病(CTE)。简单 干预措施，如将患者从危险环境中移出，可以通过以下方式预防这些并发症 让大脑有时间痊愈，防止进一步的伤害。 现场、急诊科甚至初级保健办公室的结核分枝杆菌感染的管理是 由于缺乏安全、简单和敏感的工具来帮助进行诊断和 追踪病人的康复情况。 Rebion生产了一种便携式设备--具有令人信服的初步试验数据--用于识别和监控 创伤性脑损伤患者通过视网膜扫描的方式。该设备已获得美国食品和药物管理局的批准(DEN 130051) 用于识别儿童错位的眼睛，已经显示出可以准确地识别轻度创伤的急性发作 脑损伤(MTBI)，并跟踪符合医学诊断的患者的恢复。该设备被称为 HITT，头部和眼内创伤测试设备。 正在请求提供支持，以支持HITT设备的进一步开发，以便可以现场使用 可在更大规模的临床研究中部署。到目前为止收集的数据已经导致了更好的 了解制造HITT设备所需的算法和电子要求 外行用户可以使用--并且可以解释--。 项目里程碑的成功执行将导致关键的临床研究，这些研究将接受FDA的审查。 这些研究的数据将提交给FDA，以考虑HITT设备的市场许可。

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.