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

改善术前儿科患者大脑功能图谱的行为反馈和奖励

• 批准号: 10707227
• 负责人: Ken Bruener
• 金额: $ 19.88万
• 依托单位: TURING MEDICAL TECHNOLOGIES INC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-20 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10707227
• 关键词: Aphasia; Attention deficit hyperactivity disorder; Behavioral; Biofeedback; Brain; Brain Mapping; Brain region; Child; Childhood; Clinical; Cognitive deficits; Complex; Computer software; Consumption; Data; Development; Dreams; Effectiveness; Electric Stimulation; Enrollment; Environment; Epilepsy; Excision; Failure; Feedback; Fingers; Functional Magnetic Resonance Imaging; Funding; Hand; Head; Image; Individual; Informal Social Control; Institution; Interruption; Intervention; Intractable Epilepsy; Language; Language Disorders; Letters; Magnetic Resonance Imaging; Maps; Marketing; Measures; Medical; Monitor; Motion; Motor; Movement; Names; Neurodevelopmental Deficit; Operative Surgical Procedures; Outcome; Paralysed; Patients; Pediatrics; Phase; Physicians; Research; Rewards; Risk; Running; Safety; Scanning; Schedule; Seizures; Signal Transduction; Small Business Innovation Research Grant; Small Business Technology Transfer Research; Speech; Surgeon; Technology; Testing; Time; Update; awake; base; childhood epilepsy; clinic ready; cohort; data quality; developmental psychology; experience; improved; innovation; mortality; motor deficit; neurodevelopment; neurosurgery; non-compliance; novel; pediatric patients; psychologic; success; tool; usability

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.

项目摘要/摘要 这种心理技术SBIR/STTR Fast-Track建议的目的是提供创新的 游戏化生物反馈解决方案（仅软件）以提高功能磁共振的有效性 小儿神经外科外科计划的成像（fMRI）。将癫痫焦点的最大安全切除到 优化结果与对关键大脑区域的影响仔细平衡，这可能导致 神经发育缺陷。为了避免失语或瘫痪等缺陷，外科医生依靠外科医师 功能性大脑映射以定义边界以进行安全切除。黄金标准，侵入性功能性脑图 通过皮质刺激（EC）很复杂，耗时并带有医疗风险（例如癫痫发作）。这是 对于儿童来说，极具挑战性，可以容忍通常不舒服的电刺激。 FDA清除了非 - 入侵fMRI是功能映射的更安全的替代方案。不幸的是，fMRI尚未发挥全部潜力 在儿科。低至0.2 mm的运动会导致fMRI信号的失真。临床fMRI任务也是 秘密执行（即没有公开的语音，没有按钮按下的记录）。生成功能图 事后，因此扫描操作员和患者不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而导致的90％临床小儿fMRI失败率。 Nous Imaging Inc. 开发了FDA 510（k）切实的框架框架集成的实时MRI监控（FIRMEM）软件用于跟踪 运动及其影响。使用Firmm可以大大提高获得可用的fMRI地图的机会， 儿童的运动损失率降低了50％。 FINDM目前将脑运动显示为 实时扫描操作员和患者，使扫描操作员干预和患者自我调节。在这个 快速轨道应用程序，我们将使用Gamifiend Biofefback和 任务合规性跟踪，提供一种新的，神经开发的基于生物反馈的质量 小儿临床fMRI的改进解决方案。在第一阶段，我们将开发并验证firmm qx作为一种工具 由于不合规，运动或两者兼而有之，大大减少了fMRI映射失败。在第二阶段，我们将证明 没有实时QC和Biofefback，Firmm QX优于fMRI，提供了更准确的地图和 小儿癫痫手术计划的降低非侵入性大脑图率。 Nordicneurolab（NNL）是 fMRI硬件和软件的领先供应商，用于> 2000年在全球> 2000机构的fMRI。然而， 每当收集质量不足FMRI数据时，NNL fMRI失败。一种新的协同伙伴关系 NOUS和NNL将为NNL fMRI添加Firmm QX实时运动和任务合规性改进。 nous 将提供发展心理学专业知识，而NNL提供一流的fMRI硬件，后 处理和大型分销网络。将Firmm QX添加到NOUS组合和NNL用户群中 为儿童做癫痫手术更好，更安全。