TBI identification and monitoring through retinal scanning

通过视网膜扫描进行 TBI 识别和监测

基本信息

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
项目类别：
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

项目摘要

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.

项目概要/摘要 TBI（创伤性脑损伤）是 1 岁以下个体长期残疾和死亡的主要原因 45. 美国每年报告超过 250 万例 TBI 病例，约有 3-500 万人患有与 TBI 相关的残疾的患者中，约 75% 被诊断为 mTBI。很难诊断，因为病史往往不完整，症状不具有特异性，并且与广泛的疾病重叠尽管大多数 mTBI 患者能够完全康复，但比例高达 20%。经历过多次 mTBI 的人出现持续性损伤后症状的风险会增加，并且不会出现这种情况。长期并发症，包括严重的后遗症，例如慢性创伤性脑病（CTE）。将患者从危险环境中转移等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受伤。现场、急诊科甚至初级保健办公室的 mTBI 管理是由于缺乏安全、简单且灵敏的工具来协助诊断和治疗，情况变得更加复杂。跟踪患者的康复情况。 Rebion 生产了一种便携式设备，具有令人信服的初步试验数据，用于识别和监控该设备已获得 FDA 许可（DEN 130051）。用于识别儿童眼睛错位，已证明可以准确识别轻度创伤的急性发作该设备被称为脑损伤（mTBI）并跟踪与医学诊断相符的患者康复情况。 HITT，头部和眼内创伤测试设备。正在请求拨款支持以支持 HITT 设备的进一步开发，以便其可以投入使用可在更大规模的临床研究中部署迄今为止收集的数据带来了更好的效果。了解制造 HITT 设备所需的算法和电子要求可供非专业用户使用和解释。项目里程碑的成功执行将带来关键的临床研究，这些研究将由 FDA 审查。研究数据将提交给 FDA，以考虑 HITT 设备的市场许可。