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快速通道提案的目的是提供一个创新的 游戏化生物反馈解决方案（仅限软件），可提高功能性磁共振的有效性 用于小儿神经外科手术前计划的成像（fMRI）。癫痫病灶的最大安全切除， 优化结果与对关键大脑区域的影响进行了仔细的平衡， 神经发育缺陷为了避免失语或瘫痪等缺陷，外科医生依靠术前 功能性脑标测以确定安全切除的边界。金标准，侵入性脑功能标测 通过皮层电刺激（ECS）进行的电刺激是复杂的、耗时的并且具有医疗风险（例如癫痫发作）。是 对于儿童来说，忍受经常不舒服的电刺激是非常具有挑战性的。FDA批准的非 有创性功能磁共振成像是一种更安全的功能定位方法。不幸的是，功能磁共振成像还没有充分发挥其潜力， 在儿科。低至0.2 mm的运动会导致fMRI信号失真。临床功能磁共振成像任务也 秘密地执行（即，没有公开讲话，没有按下按钮的记录）。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- 由于运动和任务依从性差，90%的临床儿科fMRI失败率。NOUS成像公司具有 开发了FDA 510（k）批准的Framewise集成实时MRI监测（FIRMM）软件， 运动及其影响。使用FIRMM可以大大提高获得可用fMRI图的机会， 降低儿童因运动而导致的fMRI数据丢失率>50%。FIRMM目前显示大脑运动到 实时扫描操作员和患者，实现扫描操作员干预和患者自我调节。在这 快速通道应用程序，我们将通过游戏化生物反馈将开发从FIRMM扩展到FIRMM Qx， 任务依从性跟踪，以提供新的、神经发育适当的、基于生物反馈的质量 儿科临床fMRI改进方案。在第一阶段，我们将开发和验证FIRMM Qx作为工具， 大大减少了由于不顺应性、运动或两者导致的fMRI映射失败。在第二阶段，我们将展示 FIRMM Qx比没有实时QC和生物反馈的fMRI更上级，提供更准确的地图， 更低的非侵入性脑标测失败率，用于儿科癫痫手术规划。NordicNeuroLab（NNL） 功能磁共振成像硬件和软件的领先供应商，用于功能磁共振成像在全球超过2000机构。然而，在这方面， 当收集的fMRI数据质量不足时，NNL fMRI失败。一个新的协同伙伴关系， NOUS和NNL将为NNL fMRI添加FIRMM Qx实时运动和任务依从性改进。NOUS 将提供发展心理学知识，而NNL提供一流的功能磁共振成像硬件，后， 加工和大型分销网络。将FIRMM Qx添加到NOUS产品组合和NNL用户群中， 使小儿癫痫手术更好、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.