XCSITE 200: Cloud-Enabled Transcranial Current Stimulation Research Solution for Multisite Studies

XCSITE 200：适用于多站点研究的云支持经颅电流刺激研究解决方案

• 批准号: 9907250
• 负责人: Flavio Frohlich
• 金额: $ 44.99万
• 依托单位: PULVINAR NEURO LLC
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-11 至 2021-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9907250
• 关键词: Acceleration; Address; Behavior; Behavioral; Benchmarking; Brain; Case Study; Central Nervous System Diseases; Clinical; Clinical Research; Clinical Trials Design; Custom; Data; Data Set; Development; Devices; Disease; Double-Blind Method; Electroencephalography; Engineering; Feedback; Future; Goals; Gold; Grant; Health; Home environment; Human; Infrastructure; Intuition; Letters; Measures; Mental Depression; Mental disorders; Neurologic; Neuronal Plasticity; Neurons; Neurosciences; Neurosciences Research; Outcome; Output; Participant; Patients; Pattern; Phase; Physiological; Pilot Projects; Placebos; Pulvinar structure; Research; Research Design; Research Personnel; Role; Sampling; Sampling Studies; Scalp structure; Schizophrenia; Short Interspersed Nucleotide Elements; Signal Transduction; Site; System; Technology; Testing; Validation; Work; base; behavioral outcome; cloud based; cost; design; effective therapy; flexibility; innovation; millisecond; next generation; novel; novel strategies; phase 2 study; placebo controlled study; product development; programs; rapid growth; recruit; research study; response; success; tool; treatment strategy

PROJECT SUMMARY – Pulvinar Neuro LLC, FROHLICH Transcranial current stimulation is a form of non-invasive brain stimulation that has recently become a key tool in human neuroscience research and has emerged as a potential treatment strategy for psychiatric disorders such as depression and schizophrenia. Yet, many questions about TCS remain unanswered and its clinical potential has not yet been delineated. We believe a key reason for this is that current TCS research devices do not have the required features for double-blind, placebo controlled studies of targeted stimulation waveforms. The objective of this proposal is to develop the XCSITE 200, a transformative TCS research device which will build upon our XCSITE platform. The XCSITE 200 will allow the study of more targeted stimulation waveforms that carry the promise of increased efficacy in terms of target engagement and behavior outcomes. In addition, XCSITE 200 devices will be managed via the cloud and thus enable cheaper and more effective administration of large, multi-site studies, which are essential in order for the technology to reach FDA clearance. In this Phase I project, we propose to implement custom-waveform and feedback stimulation in XCSITE 200 as well as perform extensive testing both at the bench and in a human pilot study (Aim 1) and to finalize and bench-test the cloud-based device and study management infrastructure (Aim 2). Quantitative milestones for both proposed aims are defined based on component and systems test benchmarks. The development of XCSITE 200 will enable the next generation of large-scale TCS studies with individualized and adaptive stimulation strategies targeting specific brain activity patterns to investigate their causal role in behavior and treat psychiatric disorders caused by altered brain network dynamics (e.g., depression and schizophrenia).

项目摘要 – Pulvinar Neuro LLC，FROHLICH 经颅电流刺激是一种非侵入性脑刺激，最近已成为关键 人类神经科学研究的工具，并已成为精神病学的潜在治疗策略 抑郁症和精神分裂症等疾病。然而，有关 TCS 的许多问题仍未得到解答 其临床潜力尚未被描述。我们认为造成这种情况的一个关键原因是当前的 TCS 研究 设备不具备目标刺激双盲、安慰剂对照研究所需的功能 波形。该提案的目标是开发 XCSITE 200，一项变革性的 TCS 研究 设备将构建在我们的 XCSITE 平台上。 XCSITE 200 将允许研究更有针对性的 刺激波形有望提高目标参与和效率 行为结果。此外，XCSITE 200 设备将通过云进行管理，从而实现更便宜的 以及更有效地管理大型、多地点研究，这对于技术的发展至关重要 以获得 FDA 许可。在这个第一阶段项目中，我们建议实现自定义波形和反馈 在 XCSITE 200 中进行刺激，并在工作台和人体试点研究中进行广泛的测试 （目标 1）并最终确定和测试基于云的设备和研究管理基础设施（目标 2）。 根据组件和系统测试定义了两个拟议目标的定量里程碑 基准。 XCSITE 200 的开发将使下一代大规模 TCS 研究成为可能 针对特定大脑活动模式进行个性化和适应性刺激策略进行研究 它们在行为中的因果作用以及治疗由大脑网络动态改变引起的精神疾病（例如， 抑郁症和精神分裂症）。