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

项目总结- Pulvinar Neuro LLC，FROHLICH 经颅电流刺激是一种非侵入性脑刺激，最近已成为一个关键 人类神经科学研究的工具，并已成为精神疾病的潜在治疗策略。 例如抑郁症和精神分裂症。然而，关于TCS的许多问题仍然没有答案， 其临床潜力尚未被描述。我们认为这其中的一个关键原因是目前的TCS研究 器械不具备靶向刺激的双盲、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，这是一项变革性的TCS研究 该设备将建立在我们的XCSITE平台上。XCSITE 200将允许更有针对性的研究 在目标接合方面具有增加功效的承诺的刺激波形， 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、多中心研究，这对于技术的发展至关重要。 才能拿到食品药品管理局的许可在这个第一阶段的项目中，我们建议实现自定义波形和反馈 在XCSITE 200中进行刺激，并在实验室和人体试验研究中进行广泛的测试 (Aim 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）。 基于组件和系统测试，定义了两个拟议目标的量化里程碑 基准。XCSITE 200的开发将使下一代大规模TCS研究成为可能 通过针对特定大脑活动模式的个性化和自适应刺激策略来研究 它们在行为中的因果作用，并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）。

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).