An Integrated Neurochemical/Electrophysiological Recording and Neuromodulation System for Basic and Clinical Research

用于基础和临床研究的集成神经化学/电生理记录和神经调节系统

• 批准号: 10477708
• 负责人: Kevin Elliott Bennet
• 金额: $ 42.98万
• 依托单位: WINCS INTERNATIONAL, LLC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-12 至 2023-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10477708
• 关键词: Action Potentials; Adenosine; Amplifiers; Animal Model; Area; Basic Science; Brain; Brain region; Clinic; Clinical; Clinical Protocols; Clinical Research; Communities; Complex; Computer software; Custom; Data; Deep Brain Stimulation; Development; Devices; Documentation; Dopamine; Electric Stimulation; Electrochemistry; Electrodes; Electrophysiology (science); Elements; Engineering; Ensure; Epilepsy; Essential Tremor; Event; FDA approved; Family suidae; Feedback; Functional disorder; Future; Goals; Human; International; Investigation; Laboratories; Learning; Link; Lobectomy; Measurement; Measures; Medical; Mental Depression; Microelectrodes; Modality; Monitor; Neurosciences; Neurosciences Research; Neurosurgical Procedures; Neurotransmitters; Noise; Norepinephrine; Obsessive-Compulsive Disorder; Operative Surgical Procedures; Outcome; Parkinson Disease; Patients; Pattern; Periodicity; Phase; Preparation; Procedures; Process; Protocols documentation; Recording of previous events; Regulation; Research Personnel; Research Subjects; Resolution; Rest; Safety; Scanning; Sensitivity and Specificity; Series; Serotonin; Signal Transduction; Small Business Technology Transfer Research; System; Techniques; Technology; Testing; Time; Tissues; Toxicology; United States National Institutes of Health; Validation; base; carbon fiber; computer science; design; extracellular; good laboratory practice; graphical user interface; high dimensionality; implantation; innovation; instrument; manufacturing process; meetings; motor behavior; multimodality; neurochemistry; neurophysiology; neuroregulation; neurosurgery; neurotransmission; next generation; novel; phase change; porcine model; pre-clinical; relating to nervous system; response; reward processing; safety study; software development; spatiotemporal; user friendly software; user-friendly; wireless

PROJECT SUMMARY WINCS International LLC, in partnership with Mayo Clinic, proposes to develop and demonstrate a highly innovative next-generation clinical instrument together with custom user-friendly display and analysis software. For the first time, the Multifunctional Apparatus for Voltammetry, Electrophysiology, and Neuromodulation (MAVEN) will offer wireless voltammetric sensing of multiple neurotransmitters (e.g., dopamine, serotonin, and adenosine) at carbon-fiber microelectrodes. MAVEN can be applied to a broad range of clinical neuroscience research subjects involving brain neurosurgeries. Alongside these multiple neurochemical sensing capabilities, the device will be capable of near-simultaneous electrophysiological (e.g., action and local field potentials) recordings. The main innovation of the MAVEN system is to include state-of-the-art voltammetric techniques to quantitatively measure both phasic (stimulation-induced) and tonic (resting) concentration levels of neurochemicals in real-time and near-simultaneously with other recording modalities. This capability is currently unavailable in clinical neuroscience research. In addition, multiple cyclic square wave voltammetry (MCSWV) will enable second-to-second quantitative measurements of tonic extracellular levels of dopamine and serotonin with exceptional spatial resolution, sensitivity, specificity, and minimal tissue disturbance. This proposal employs our unique combined expertise in neuroscience, electrochemistry, engineering, and software development to validate this novel clinical research instrument in preparation for its use during intraoperative clinical neurosurgeries. Also, combining electrophysiology and electrochemical technologies would enable investigators to probe unexplored links between the abnormal activity of neural elements and the dopaminergic, serotonergic, purinergic (adenosine) dynamics associated with neuropsychopathologies, such as Parkinson’s disease, essential tremor, obsessive-compulsive disorder, depression, and epilepsy. Our large animal model (swine) studies emulating existing human intraoperative neurosurgical procedures will provide essential information to guide and inform the finalization of the MAVEN design for use by the clinical neuroscience community in future IDE-enabled mechanistic clinical studies. Our proposal seeks to (1) finalize the development of MAVEN, together with a sophisticated user-friendly software interface that (2) meets device manufacturing processes, regulatory Design Control, and medical safety requirements to obtain an FDA-approved Investigational Device Exemption (IDE), and (3) use a swine model to develop MAVEN stimulation and recording protocols for use in existing intraoperative neurosurgical procedures (e.g., deep brain stimulation neurosurgeries and cortical lobectomies). This includes demonstrating the functionality, versatility, and efficacy of the MAVEN system for future pre-clinical and clinical neuroscience research.

项目摘要 WINCS国际有限责任公司与马约诊所合作，建议开发和展示一种高度 创新下一代临床仪器以及用户友好的定制显示和分析软件。 第一次，多功能仪器伏安法，电生理学，和神经调节 （MAVEN）将提供多种神经递质的无线伏安传感（例如，多巴胺血清素 腺苷）在碳纤维微电极上。MAVEN可广泛应用于临床神经科学 涉及脑神经外科的研究课题。除了这些多种神经化学传感能力， 该装置将能够几乎同时进行电生理学（例如，动作电位和局部场电位） 录音. MAVEN系统的主要创新是包括最先进的伏安技术， 定量测量相位（刺激诱导）和紧张（静息）浓度水平， 神经化学物质的实时和几乎同时与其他记录方式。这种能力是 目前在临床神经科学研究中尚不可用。此外，多次循环方波伏安法 （MCSWV）将能够对多巴胺的紧张性细胞外水平进行秒到秒的定量测量 和5-羟色胺，具有优异的空间分辨率、灵敏度、特异性和最小的组织干扰。这 该提案采用了我们在神经科学、电化学、工程和软件方面的独特综合专业知识 开发，以验证这种新型临床研究仪器，为术中使用做准备 临床神经外科此外，结合电生理学和电化学技术将使 研究人员探索神经元的异常活动与神经元的异常活动之间未被探索的联系。 与神经精神病理学相关的多巴胺能、多巴胺能、嘌呤能（腺苷）动力学， 如帕金森氏病、原发性震颤、强迫症、抑郁症和癫痫。我们的大型 模拟现有人类术中神经外科手术的动物模型（猪）研究将提供 指导和告知临床使用的MAVEN设计定稿的基本信息 神经科学界在未来的IDE启用机制的临床研究。 我们的建议旨在（1）完成MAVEN的开发，以及一个复杂的用户友好的 软件接口（2）满足器械制造过程、监管设计控制和医疗 获得FDA批准的试验用器械豁免（IDE）的安全性要求，以及（3）使用猪 用于开发MAVEN刺激和记录协议的模型，用于现有的术中神经外科手术 程序（例如，深部脑刺激神经外科手术和皮质叶切除术）。这包括展示 MAVEN系统在未来临床前和临床神经科学中的功能、通用性和有效性 research.