High-Field MR Compatible Dense Array EEG using Polymer Thick Film Technology

使用聚合物厚膜技术的高场 MR 兼容密集阵列脑电图

• 批准号: 9112011
• 负责人: Catherine Poulsen
• 金额: $ 59.2万
• 依托单位: ELECTRICAL GEODESICS, INC.
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-08-01 至 2018-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9112011
• 关键词: Adhesives; Adoption; Adult; Auditory; Basic Science; Biocompatible Coated Materials; Brain; Brain imaging; Carbon nanoparticle; Childhood; Clinical; Computer software; Copper; Custom; Data; Data Quality; Development; Devices; Disease; Effectiveness; Electrodes; Electroencephalography; Electrolytes; Ensure; Epilepsy; Film; Functional Magnetic Resonance Imaging; Functional disorder; Gel; General Hospitals; Goals; Gold; Head; Health; Heating; Height; Housing; Human; Image; Imaging technology; Ink; Joints; Knowledge; Lead; Legal patent; Length; Magnetic Resonance Imaging; Magnetoencephalography; Marketing; Massachusetts; Measurement; Methods; Modeling; Morphologic artifacts; Multimodal Imaging; Neurons; Operative Surgical Procedures; Pathology; Performance; Phase; Polymers; Positron-Emission Tomography; Printing; Procedures; Production; Property; Protocols documentation; Research Personnel; Resolution; Rest; Safety; Sampling; Scanning; Science; Scientist; Side; Signal Transduction; Small Business Innovation Research Grant; Source; Specific qualifier value; Speed; Structure; System; Technology; Temperature; Testing; Thick; Time; Transcranial magnetic stimulation; Visual; Width; Work; biomaterial compatibility; clinically relevant; cost; cost effective; cost effectiveness; data integrity; density; design; flexibility; improved; innovation; insight; magnetic field; manufacturing scale-up; meetings; meter; neuroimaging; neuropathology; neurovascular coupling; novel; patient safety; performance tests; prototype; quality assurance; relating to nervous system; repaired; safety testing; sensor; simulation; spatiotemporal; success; temporal measurement; tool

DESCRIPTION (provided by applicant): The goal of this SBIR project is to design a low-profile, high-resistive, MR-compatible dense-array EEG (dEEG) sensor net for simultaneous dEEG/fMRI recordings in fields as high as 7 Tesla. This novel sensor net, the "InkNet", will provide safe, noninvasive, and affordable dEEG/fMRI technology to both clinicians and researchers, thereby enabling routine multimodal imaging of human brain function with unprecedented spatiotemporal resolution. Application of this technology will enhance basic science of healthy brain function, as well as treatment of many neural pathologies and pre-surgical planning. The InkNet will overcome current cross-modal safety and artifact issues that have so far severely limited the effectiveness of simultaneous dEEG/fMRI by leveraging expertise in innovative polymer thick film (PTF) technology at the A. A. Martinos Center, Massachusetts General Hospital and dEEG sensor net design and technology expertise at Electrical Geodesics Inc. (EGI). In Phase I, we established feasibility with the development and testing of our first 256- channel InkNet prototype using screen-printed high-resistive PTF ink leads interfaced with EGI's patented geodesic net structure and MR-compatible EEG acquisition hardware and software. Phase II will build on the successes of our Phase I prototype while working to refine its design, enhance production manufacturability and cost efficiency, and conduct performance and safety tests. Specific Aim 1 is to study the latest innovations in flexible and stretchable substrates and conductive inks to improve conformability and electrode contact, and reduce MR-induced ballistocardiogram artifact. Sample circuits using the best candidate materials will be printed in-house and put to rigorous testing for optimal performance in high MR fields. Specific Aim 2 will refine the InkNet design, including an electrode pedestal with an ultra low profile of d4 mm to fit in tight MR head coils, and a novel lead layout enabled by state-of-the-art inkjet printing of leads up to 2.5 meters in length, double-sided, 5-mil trace width, and te novel, flexible materials. Specific Aim 3 will implement the new design and materials to produce Phase II 256-channel InkNet prototypes using QA production and test procedures and new, custom-designed assembly and test fixtures to enhance speed and reliability. Specific Aim 4 will test and validate the Phase II prototype for human safety and data integrity. Safety tests will be performed using finite difference time domain (FDTD) numerical simulations with an anatomically accurate head model, followed by actual temperature measurements using a specially developed phantom (CHEMA) and high-power TSE imaging sequences that induce RF heating. After confirming safety, MRI and EEG data integrity will be tested at 3T and 7T field strengths using clinically relevant structural scans, and fMRI/EEG resting, visual and auditory protocols. Data quality will be compared to data from EEG-only and MRI-only sessions, and against data from a commercial MR-compatible net built with traditional copper wire technology. Our test plan will be reviewed with FDA and adjusted where required to meet requirements for a 510K predicate application.

描述（由申请人提供）：该SBIR项目的目的是设计低调，高抗性的，兼容MR兼容的密集阵列EEG（DEEG）传感器网，用于同时在高达7 Tesla的领域中的DEEG/FMRI录音。这个新颖的传感器网络“缝制”将为临床医生和研究人员提供安全，无创和负担得起的DEEG/FMRI技术，从而以前所未有的时空分辨率实现了人脑功能的常规多模式成像。该技术的应用将增强健康脑功能的基础科学，并治疗许多神经病理和手术前的计划。 inknett将通过利用A. A. Martinos Center，Massachusetts A. A. Martinos Center，Massachusetts General Hospital Hospital and Deeg Sensor Net Design and Technology Electrical Geodesices INC（EGI）的专业知识来克服迄今严重限制同时DEEG/fMRI的有效性，这些问题将严重限制了同时DEEG/fMRI的有效性。在第一阶段，我们使用屏幕打印的高电阻PTF墨水引线来建立了对我们的第一个256通道原型的开发和测试的可行性，与EGI专利的Geodesic净结构和MR兼容的EEG EEG采集硬件和软件相连。第二阶段将建立在我们I期原型的成功基础上，同时致力于完善其设计，增强生产的生产性和成本效率，并进行性能和安全测试。特定目标1是研究灵活的最新创新 以及可拉伸的底物和导电墨水，以提高可比性和电极接触，并减少MR诱导的ballistarcardiogram伪像。使用最佳候选材料的样品电路将在内部印刷，并进行严格的测试，以在高MR领域中进行最佳性能。特定的AIM 2将完善缝制设计，包括带有Ultra的电极基座 D4 mm的低剖面可适合紧密的MR头圈，并通过最新的铅喷墨印刷长达2.5米，双面，5米的痕量宽度和TE小说，灵活的材料来实现新颖的线索布局。特定的目标3将使用QA生产和测试程序以及新的定制设计的组装和测试固定装置来实施新的设计和材料，以生产II阶段256通道原型，以提高速度和可靠性。特定的目标4将测试和验证II期原型的人体安全和数据完整性。安全测试将使用具有解剖学上精确的头部模型的有限差时间域（FDTD）数值模拟进行，然后使用特殊开发的幻影（ChemA）和高功率TSE成像序列进行实际温度测量，从而诱导RF加热。确认安全性后，将使用临床相关的结构扫描以及fMRI/EEG休息，视觉和听觉方案在3T和7T场强度下测试MRI和EEG数据完整性。将数据质量与仅限脑电图和仅MRI的数据进行比较，并将其与传统铜线技术构建的商业MR兼容网络的数据进行比较。我们的测试计划将通过FDA进行审查，并在需要的情况下进行调整以满足510K谓词应用程序的要求。