I-Corps: An Integrated Hardware/Software System to Predict Cognitive Outcome in Neurosurgery Patients

I-Corps项目更广泛的影响/商业潜力是创建一个交钥匙软件平台，支持脑损伤患者的认知行为测试，将大脑功能和结构图与行为测试结果相结合，并将患者结果的实时可操作预测反馈给临床医生。该软件平台将在清醒开颅术的特定利基领域开发-神经外科手术过程中，患者在部分手术中不处于麻醉状态，以便他/她可以参与认知测试。通过在清醒开颅手术（美国200个主要医疗中心每年约2000例）中开发这项技术，有可能确定最具信息量的数据，以改进有关患者长期预后的实时预测模型。虽然该平台的核心预测分析最终将在更广泛的临床人群（例如中风）中进行推广测试，但神经外科市场的发展利用了该市场的预计增长，从2016年的130亿美元增长到2026年的270亿美元（复合年增长率为8.2%）。这项技术将为临床医生提供对患者未来认知功能的定量预测，使医生能够增加成功治疗的可能性，同时保护患者更高的生活质量。I-Corps项目将支持更深入地了解临床市场，以及拟议的技术在何处以及如何解决神经外科团队在管理复杂病例时面临的障碍。在I-Corps项目期间，目标是与技术可能接触到的各种潜在客户、用户、影响者和推荐者进行交流，包括：神经外科医生、神经麻醉师、神经科医生、神经心理学家、神经生理学家、神经放射科医生、医师助理、护士、技术人员、患者和医院采购管理人员。最终，这项技术通过为外科医生提供手术室中关于病人未来生活质量的实时洞察，具有改变神经外科实践的巨大潜力。该软件平台的原型已经在美国一家大型医疗中心的3名外科医生的35名患者中进行了试点。这个I-Corps项目的一个关键目标是了解不同医疗中心和临床医生在工作流程中的差异，以及不同的临床医生如何处理在清醒开颅手术过程中可能出现的具体挑战。这对于开发一种灵活而强大的产品至关重要，这种产品可以与全国现有的临床方案相结合，以支持对患者结果的个性化预测。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

The broader impact/commercial potential of this I-Corps project is to create a turn-key software platform, that supports cognitive behavioral testing of patients with brain lesions, integrates maps of brain function and structure with the results of behavioral testing, and returns real-time actionable predictions about patient outcome to clinicians. This software platform will be developed in the specific niche of awake craniotomies - neurosurgical procedures where the patient is not under anesthesia for part of the surgery in order that s/he can participate in cognitive testing. By developing this technology in the setting of awake craniotomies (~2,000/year at 200 major US medical centers), it is possible to identify the most informative data to improve real-time predictive models about long-term patient outcome. While the predictive analytics at the heart of this platform eventually will be tested for generalization in a wider range of clinical populations (e.g., stroke) development within the neurosurgery market capitalizes on the projected growth of this market from $13B in 2016 to $27B by 2026 (with an 8.2% compound annual growth rate). This technology will provide clinicians with quantitative predictions about future cognitive function in patients, allowing doctors to increase the likelihood of successful treatment while protecting a higher quality of life in patient outcome.This I-Corps project will support a deeper understanding of the clinical market and where and how the proposed technology can address impediments currently faced by neurosurgical teams when managing complex cases. During the I-Corps program, the goal is to speak with a variety of potential customers, users, influencers and recommenders who the technology may touch, including: neurosurgeons, neuro-anesthesiologists, neurologists, neuropsychologists, neurophysiologists, neuro-radiologists, physician assistants, nurses, technical staff, patients and hospital purchasing administrators. Ultimately, this technology holds tremendous potential to change neurosurgical practice by providing surgeons with real-time insights in the operating room about a patient's future quality of life. A prototype of the software platform has been piloted with 35 patients across 3 surgeons at a single major US medical center. A key goal of the this I-Corps project is to understand differences across medical centers and clinicians in workflow and how different clinicians manage the specific challenges that can arise during awake craniotomy procedures. This is critical for developing a product that is agile and robust and which can be integrated with existing clinical protocols across the country to support personalized predictions of patient outcome.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.