Behavioral feedback and rewards for improving functional brain mapping in presurgical pediatric patients

项目摘要/摘要 这项心理技术SBIR/STTR快速通道提案的目标是提供一种创新的 游戏化生物反馈解决方案(仅限软件)可提高功能磁共振的有效性 儿童神经外科手术前计划的成像(FMRI)。最大限度安全切除癫痫灶以 优化结果与对关键大脑区域的影响进行了仔细的平衡，这可能会导致 神经发育缺陷。为了避免失语症或瘫痪等缺陷，外科医生依赖于手术前 脑功能图以确定安全切除的边界。黄金标准，有创功能脑图 经皮质电刺激(ECS)是一种复杂、耗时且具有医疗风险(如癫痫发作)的方法。它是 对孩子来说，忍受经常令人不舒服的电刺激是极具挑战性的。FDA批准了非 侵入性功能磁共振成像是一种更安全的功能标测方法。不幸的是，功能磁共振成像尚未充分发挥其潜力。 在儿科。低至0.2 mm的运动会导致fMRI信号失真。临床功能磁共振任务还包括 秘密执行(即，没有公开的讲话，没有按钮按下的录音)。生成功能图 事后，因此扫描操作员和患者无法知道是否收集了足够的可用数据，导致50- 90%的临床儿科功能磁共振失败率是由于运动和任务依从性差。NOS成像公司拥有 开发用于跟踪的FDA 510(K)清除的Framewise集成实时MRI监控(FIRMM)软件 运动及其效果。使用FIRMM可以极大地提高获得可用的fMRI地图的机会， 将儿童运动引起的功能磁共振数据丢失率降低50%。FIRMM目前将大脑运动显示到 实时扫描操作员和患者，支持扫描操作员干预和患者自我调节。在这 快速通道应用程序，我们将扩展开发从FIRMM到FIRMM QX的游戏化生物反馈和 任务遵从性跟踪，以提供新的、适合神经发育的、基于生物反馈的质量 儿科临床功能磁共振成像的改进方案。在第一阶段，我们将开发和验证FIRMM QX作为一种工具 大大减少因不合规、运动或两者兼而有之而导致的fMRI映射失败。在第二阶段，我们将演示 FIRMM QX优于没有实时质控和生物反馈的fMRI，提供更准确的地图和 儿童癫痫手术计划中无创脑图失败率较低。北欧神经实验室(NordicNeuroLab) 领先的功能磁共振硬件和软件供应商，用于全球范围内的功能磁共振成像AT&GT；2000机构。然而， 只要未收集到足够高质量的fMRI数据，NNL fMRI就会失败。一种新的、协同的合作伙伴关系， NOUS和NNL将在NNL功能磁共振的基础上增加FIRMM QX实时运动和任务遵从性改进。诺斯 将提供发展心理学知识，而NNL提供同类最好的功能磁共振硬件，后 加工和庞大的分销网络。将FIRMM QX添加到NOU产品组合和NNL用户群将 让儿童癫痫手术更好、更安全。

Project Abstract/Summary The objective of this psychological technology SBIR/STTR Fast-Track proposal is to provide an innovative gamified biofeedback solution (software-only) to improve the effectiveness of functional Magnetic Resonance Imaging (fMRI) for pediatric pre-neurosurgical planning. Maximal safe resection of an epileptic focus to optimize outcome is carefully balanced against impact on critical brain regions that could result in neurodevelopmental deficits. To avoid deficits such as aphasia or paralysis, surgeons rely on pre-surgical functional brain mapping to define borders for safe resection. Gold standard, invasive functional brain mapping via electrocortical stimulation (ECS) is complex, time consuming and carries medical risks (e.g. seizures). It is extremely challenging for children, to tolerate the often-uncomfortable electrical stimulation. FDA cleared non- invasive fMRI is a safer alternative for functional mapping. Unfortunately, fMRI has yet to reach its full potential in pediatrics. Motion as low as 0.2 mm causes distortion of the fMRI signal. Clinical fMRI tasks are also performed covertly (i.e., no overt speech, no recording of button presses). Functional maps are generated post-hoc, so scan operators and patients cannot know if sufficient usable data were collected, resulting in 50- 90% clinical pediatric fMRI failure rates due to motion and poor task compliance. NOUS Imaging Inc. has developed FDA 510(k)-cleared Framewise Integrated Real-Time MRI Monitoring (FIRMM) software for tracking motion and its effects. Use of FIRMM can greatly improve the chances of obtaining usable fMRI maps, reducing fMRI data loss rates due to motion by >50% in children. FIRMM currently displays brain motion to the scan operator and patient in real-time, enabling scan operator intervention and patient self-regulation. In this Fast-Track application, we will extend development from FIRMM to FIRMM Qx with gamified biofeedback and task compliance tracking, to provide a new, neuro-developmentally appropriate, biofeedback-based quality improvement solution for pediatric clinical fMRI. In Phase I we will develop and verify FIRMM Qx as a tool to greatly reduce fMRI mapping failures due to non-compliance, motion or both. In Phase II, we will demonstrate that FIRMM Qx is superior to fMRI without real-time QC and biofeedback, providing more accurate maps and lower non-invasive brain mapping fail-rates for pediatric epilepsy surgery planning. NordicNeuroLab (NNL) is the leading supplier of fMRI hardware and software, used for fMRI at > 2000 institutions worldwide. However, NNL fMRI fails whenever insufficient quality fMRI data are collected. A new, synergistic partnership between NOUS and NNL will add FIRMM Qx real-time motion and task compliance improvement to NNL fMRI. NOUS will be providing developmental psychology know-how, while NNL provides best-in-class fMRI hardware, post- processing and a large distribution network. Adding FIRMM Qx, to the NOUS portfolio and NNL user base will make epilepsy surgery for children better and safer.