Sensing intracranial bioimpedance through anatomic windows for classifying stroke type

通过解剖窗感测颅内生物阻抗以对中风类型进行分类

• 批准号: 10667998
• 负责人: Ryan Joseph Halter
• 金额: $ 44.91万
• 依托单位: DARTMOUTH COLLEGE
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-15 至 2025-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10667998
• 关键词: Acute; Admission activity; Algorithms; Anatomy; Animal Model; Blood; Brain; Brain hemorrhage; Cause of Death; Centers for Disease Control and Prevention (U.S.); Cerebral hemisphere hemorrhage; Cessation of life; Classification; Clinic; Clinical; Custom; Detection; Devices; Diagnosis; Discrimination; Electrodes; Environment; Equation; Event; Feasibility Studies; Frequencies; Hemorrhage; Human Resources; Image; Incidence; Injury; Inpatients; Intervention; Intracranial Hemorrhages; Ischemia; Ischemic Stroke; Lead; Lesion; Location; MRI Scans; Maps; Measurement; Medical Care Costs; Medical emergency; Mind; Monitor; Morbidity - disease rate; Neurologic; Nurses; Ocular orbit; Patient Admission; Patient Care; Patient imaging; Patients; Penetration; Performance; Periodicals; Persons; Positioning Attribute; Prevalence; Quality of life; Recurrence; Risk; Rupture; Sampling; Scalp structure; Scanning; Site; Software Design; Specific qualifier value; Stroke; System; Techniques; Technology; Time; Tissues; Transient Ischemic Attack; Translating; Translations; United States; Validation; Vulnerable Populations; acute care; acute stroke; cohort; cost; cranium; design; disability; electric impedance; evidence base; experience; feasibility trial; high risk; human study; improved outcome; innovation; instrument; miniaturize; novel; novel strategies; patient prognosis; patient variability; post stroke; pre-clinical; programs; real time monitoring; sensor technology; simulation; skull base; standard of care; stroke recovery; technology development; technology validation

ABSTRACT “Time lost is brain lost - every minute counts” – according to the Center for Disease Control (CDC) in reference to strokes. Stroke is the 5th leading cause of death in the United States, 2nd in the world and will cost the U.S. $183 billion annually by 2030. Every year 800,000 people will suffer a stroke in the U.S. alone and this high incidence contributes to stroke being a leading cause of serious, long-term disability in the US. There are two primary types of stroke: ischemic and hemorrhagic. Ischemic stroke involves blood or fatty plaque blocking a vessel of the brain while hemorrhagic is defined by a vessel rupture or brain bleed. Each type requires significantly different treatments, and treatment of the wrong type could have lethal consequences. This makes stroke type identification crucial to receiving treatment. Thus, neurologic monitoring and timely intervention are key for acute stroke recovery, yet currently no bedside monitor capable of detecting a recurrent stroke, hemorrhagic transformation and/or evolving stroke at onset exists. Today’s standard-of-care relies on monitoring general patient vitals and periodic CT/MRI scans to image the intracranial state; unfortunately, the large time periods between scans delays possible detection of a high-consequence change in condition. With every minute of pre-intervention time equating to an increase in lasting disability odds, a real-time monitor could not only save lives, but save the quality of life for this vulnerable population. We propose to develop a small form-factor, on- scene device capable of mapping the intracranial space and differentiating ischemic from hemorrhagic stroke. During this program we will take the significant step of developing this technology with translation in mind and demonstrating proof of feasibility in a pre-clinical human study of high-risk patients undergoing monitoring after being admitted for stroke. We will develop a non-invasive sensing approach to intracranial monitoring (Aim I), a key innovation for stroke use, and validate this sensing ability in a cohort of patients being monitored following stroke (Aim II). By assessing the feasibility of our novel approach to non-invasive intracranial monitoring in a tightly controlled patient cohort (post-stroke monitoring), we can validate our ability to 1) detect the presence of stroke and 2) differentiate stroke type. This technology has the potential to not only aid in the clinic as a monitor for detecting stroke onset within patients at high-risk for recurrent stroke or worsening status, but also in the field for mobile stroke type discrimination. Because this system has a small form-factor, is non-invasive, is relatively inexpensive (<$10k for an intracranial bioimpedance monitoring system), and is potentially able to discriminate stroke type at first contact with the patient, this technology has the potential of being easily translated to and accepted by the clinic for the benefit of diagnosing or tracking patients experiencing a stroke. We expect that by the end of this program we will be in a position to optimize and miniaturize our technology and to conduct a larger human study to demonstrate efficacy of our intracranial impedance monitoring technique.

摘要 “失去的时间就是失去的大脑-每一分钟都很重要”-根据疾病控制中心（CDC）的参考文献， 到中风中风是美国的第五大死亡原因，在世界上排名第二，将花费美国。 到2030年每年1830亿美元。每年仅在美国就有80万人中风， 在美国，中风的发病率是导致严重、长期残疾的主要原因。有两 中风的主要类型：缺血性和出血性。缺血性中风涉及血液或脂肪斑块阻断一种 出血性脑血管破裂定义为血管破裂或脑出血。每种类型都需要 不同的治疗方法，错误的治疗方法可能会导致致命的后果。这使得 中风类型识别对接受治疗至关重要。因此，神经监测和及时干预是 急性中风恢复的关键，但目前没有床旁监护仪能够检测复发性中风， 在发作时存在出血性转化和/或进展性中风。今天的标准治疗依赖于监测 一般患者生命体征和定期CT/MRI扫描以成像颅内状态;不幸的是， 扫描之间的周期延迟了对状况中的重要变化的可能检测。每一分钟 干预前的时间等于增加持久的残疾几率，实时监测不仅可以节省 生命，但挽救这一弱势群体的生活质量。我们建议开发一种小型的形式因素，在- 能够映射颅内空间并区分缺血性和出血性中风的场景设备。 在这个项目中，我们将采取重要的一步，在考虑翻译的情况下开发这项技术。 并在接受监测的高风险患者的临床前人体研究中证明了可行性 在中风入院后我们将开发一种非侵入性的颅内监测传感方法（Aim I），这是中风使用的关键创新，并在受监测的患者队列中验证这种感知能力 中风后（目标II）。通过评估我们新的无创颅内监测方法的可行性， 在严格控制的患者队列（卒中后监测）中，我们可以验证我们的能力：1）检测 2）区分中风类型。这项技术不仅有可能在临床上作为监测器 用于检测卒中复发或病情恶化高危患者的卒中发作， 用于移动的笔画类型辨别。因为该系统具有小的形状因子，是非侵入性的，相对于 便宜（颅内生物阻抗监测系统<1万美元），并且可能能够区分 中风类型在第一次接触病人，这项技术有可能很容易被转化为， 被诊所接受，以利于诊断或跟踪经历中风的患者。我们预计， 该计划结束后，我们将能够优化和优化我们的技术，并进行更大的 人体研究以证明我们的颅内阻抗监测技术的有效性。