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

这个I-Corps项目的更广泛的影响/商业潜力是创建一个交钥匙软件平台，该平台支持脑损伤患者的认知行为测试，将大脑功能和结构的地图与行为测试的结果相结合，并将有关患者结果的实时可操作预测返回给临床医生。该软件平台将在清醒开颅手术的特定利基中开发-神经外科手术，其中患者在手术的一部分中没有麻醉，以便她/他可以参与认知测试。通过在清醒开颅手术（美国200家主要医疗中心每年约2，000例）的背景下开发这项技术，可以识别最具信息性的数据，以改善有关长期患者结局的实时预测模型。虽然该平台核心的预测分析最终将在更广泛的临床人群中进行推广测试（例如，中风）的发展，利用了这个市场的预计增长，从2016年的130亿美元到2026年的270亿美元（复合年增长率为8.2%）。 该技术将为临床医生提供有关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。这个I-Corps项目将支持对临床市场的更深入了解，以及拟议的技术在哪里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计划期间，目标是与技术可能接触的各种潜在客户，用户，影响者和制造商交谈，包括：神经外科医生，神经麻醉师，神经学家，神经心理学家，神经生理学家，神经放射学家，医生助理，护士，技术人员，患者和医院采购管理员。最终，这项技术具有巨大的潜力，可以通过在手术室为外科医生提供关于患者未来生活质量的实时见解来改变神经外科实践。该软件平台的原型已在美国一家主要医疗中心的3名外科医生的35名患者中试用。这个I-Corps项目的一个关键目标是了解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管理清醒开颅手术过程中可能出现的特定挑战。这对于开发一种灵活而强大的产品至关重要，该产品可以与全国现有的临床协议集成，以支持个性化的患者预后预测。该奖项反映了NSF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.