Development of an innovative neurosurgical planning tool for awake craniotomy

摘要/摘要 脑瘤会导致不成比例的癌症发病率和死亡率。护理治疗标准 包括最大限度的安全手术切除，手术切除范围(EOR)是最相关的 影响患者生存的预后因素。因为EOR取决于外科医生的辨别能力 在支持认知的脑区或邻近脑区的健康脑组织和肿瘤侵袭组织之间 神经外科医生必须在临床目标和造成认知障碍之间取得平衡。地面 促进这一区别的真实护理标准程序是清醒开颅手术，并使用直接脑标测 电刺激标测(DES)。了解关于实时外科手术的特定功能的位置 TARGET使临床团队能够保护这些功能。它也是术前行为护理的标准 收集所有脑瘤患者的数据和脑部扫描。然而，目前还没有一个基于证据的平台 这使得临床团队可以选择最敏感的任务来绘制和测量给定的大脑区域，或者 了解切除特定体积的脑组织对未来认知功能的影响。为了填满这个 Gap，MindTrace Technologies，Inc.正在开发一个基于云的软件平台，用于在 在神经外科手术后，改进评估和选择最佳治疗方案的过程。 MindTrace平台支持管理功能性脑地图协议(Functive 神经成像、DES映射)以及行为和神经数据的预处理和共同配准 清醒脑外科手术中优化脑电地形图效果的服务。这个项目的总体目标是 直接针对第二阶段SBIR的建议是进一步完善先进的MindTrace原型软件平台和 在研究研究的背景下，将其部署在IRB下，以收集4个主要医疗机构的前瞻性纵向数据 中锋。这些目标的实现将产生可商业化的产品，并奠定经验和 基于AI的实时预测分析发展的技术基础，大规模临床 试验，以及FDA的批准。本文提出的方案的设计是基于FDA的书面反馈 (qSub会议)关于成功申请突破设备所需的数据集参数 指定。这项前瞻性研究将产生的数据集将成为后续研究的经验基础 AI/ML预测分析的技术发展。 MindTrace是唯一一家将相关数据(行为、功能磁共振)与因果证据相结合的公司 清醒脑外科手术中的脑电活动及术后神经心理表现的比较 手术前的神经心理表现。将当前部署的平台商业化 Proposal代表一种交钥匙软件产品，它集成了多个信息源，以实现 临床医生更有效地计划神经外科手术，以支持最好的术后生活质量。

SUMMARY/ABSTRACT Brain tumors result in a disproportionate rate of cancer morbidity and mortality. Standard of care treatment includes maximal safe surgical resection, with extent of surgical resection (EOR) representing the most relevant prognostic factor for patient survival. Because EOR is dependent on the surgeon’s capability to distinguish between healthy brain tissue and tumor-invaded tissue in or adjacent to brain areas that support cognitive function, the neurosurgeon must balance clinical objectives against causing cognitive impairments. The ground truth standard-of-care procedure to facilitate this distinction is awake craniotomy with brain mapping using direct electrical stimulation mapping (DES). Knowing the location of specific functions with respect to real-time surgical targets allows the clinical team to protect those functions. It is also standard of care for pre-operative behavioral data and brain scans to be collected on all brain tumor patients. However, there is no evidenced-based platform that allows clinical teams to choose the most sensitive task to map and measure a given brain region, or to understand the implications for future cognitive function of removing a specific volume of brain tissue. To fill this gap, MindTrace Technologies, Inc. is developing a cloud-based software platform to be used before, during, and after a neurosurgical procedure to improve the process of evaluating and choosing an optimal treatment plan. The MindTrace platform supports the administration of functional brain mapping protocols (functional neuroimaging, DES mapping), and the pre-processing and co-registration of behavioral and neural data in the service of optimizing the effectiveness of brain mapping during awake brain surgery. The overall goal of this Direct to Phase II SBIR proposal is to further improve the advanced prototype MindTrace software platform and deploy it under IRB in the context of a research study to collect prospective longitudinal data at 4 major medical centers. Completion of these Aims will result in a commercializable product and lay the empirical and technological foundation for the development of real-time AI-based predictive analytics, a large-scale clinical trial, and FDA clearance. The design of the protocol proposed herein is based on written feedback from FDA (qSub meeting) regarding the parameters of a dataset needed for successfully apply for Breakthrough Device Designation. The dataset to be generated by this prospective study will be the empirical basis for follow on technology development in AI/ML predictive analytics. MindTrace is the only company to integrate correlational data (behavior, functional MRI) with the causal evidence generated during awake brain surgery, and the comparison of post-operative neuropsychological performance to preoperative neuropsychological performance. Commercialization of the platform deployed within the current proposal represents a turn-key software product that integrates multiple sources of information to enable clinicians to plan neurosurgery more effectively in support of the best postoperative quality-of-life.