XCSITE 300: Cloud-Enabled Closed-Loop Transcranial Current Stimulation Device for At-Home Studies

XCSITE 300：用于家庭研究的云闭环经颅电流刺激设备

• 批准号: 10698559
• 负责人: Leah Bishop Townsend
• 金额: $ 88.64万
• 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 2026-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10698559
• 关键词: Acceleration; Address; Behavior; Brain; Cephalic; Clinic; Clinical; Clinical Management; Clinical Trials; Cloud Computing; Cognition; Computer software; Controlled Clinical Trials; Data; Development; Devices; Double-Blind Method; Double-blind trial; Electroencephalography; Feedback; Future; Goals; Grant; Health; Home; Human; Individual; Infrastructure; Investigation; Laboratory Research; Left; Legal patent; Major Depressive Disorder; Market Research; Marketing; Measures; Mental Depression; Mental disorders; Monitor; Multi-Institutional Clinical Trial; Outcome; Participant; Pathologic; Patient Self-Report; Patients; Pattern; Performance; Periodicity; Persons; Phase; Pilot Projects; Psychiatry; Pulvinar structure; Randomized; Remote management; Research; Role; Schizophrenia; Site; Small Business Innovation Research Grant; Symptoms; System; Technology; Testing; Time; Translational Research; United States National Institutes of Health; Work; clinical care; clinical efficacy; cloud based; cloud platform; commercialization; design; effective therapy; electric field; feasibility testing; first-in-human; flexibility; innovation; neuronal circuitry; neurotechnology; next generation; noninvasive brain stimulation; novel; performance tests; placebo controlled study; pressure; primary outcome; programs; prototype; psychiatric symptom; recruit; remote grading; research clinical testing; response; secondary outcome; tool

PROJECT SUMMARY – Pulvinar Neuro LLC, TOWNSEND The causal role of circuit activity dynamics in depression remains poorly understood due to the lack of tools for non-invasive, targeted circuit modulation. Today’s non-invasive brain stimulation approaches apply generic stimulation waveforms without targeting individual activity signatures and without dynamically adapting stimulation to ongoing fluctuations in brain activity. To address this gap, the long-term goal of Pulvinar Neuro is to develop, evaluate, and commercialize targeted closed-loop transcranial alternating current stimulation (tACS) technology, which measures brain activity with EEG and dynamically applies weak rhythmic electric fields to modulate network oscillations. In the previous Phase 1 SBIR, Pulvinar Neuro developed XCSITE 100Pro, a closed-loop tACS device that was successfully tested for feasibility in healthy human participants, and XCSITE 200, a cloud-based platform for remote stimulation. The overall goal of this application is to develop and evaluate the XCSITE 300 platform that will integrate closed-loop capabilities with cloud-based stimulation and study management. The rationale for this project is that such a solution will drive the next generation of circuit-based research in psychiatry and that closed-loop tACS has the potential to become a safe and effective treatment for depression given the initial positive findings of open-loop tACS for the treatment of depression and the substantial unmet market need. Three specific aims will be pursued to accomplish this goal. (1) Integrate and bench test closed-loop tACS technology with cloud-based infrastructure, (2) Test XCSITE 300 for in-lab use in a pilot double-blind single-site study for the treatment of depression (XCSITE 300 Clinic), and (3) Adapt device form factor and user interface for at-home use (XCSITE 300 Home) and establish feasibility in a pilot study in people with depression. At completion of the proposed work, feasibility and preliminary efficacy of closed-loop tACS will be established and closed-loop tACS for use in a clinic and for at-home use by patients will be ready for pivotal studies for the treatment of depression. The work in this application is innovative given the lack of available cloud-enabled (“smart”) closed-loop tACS devices for probing circuit dynamics and for evaluation of clinical efficacy in rigorous double-blind trials. The proposed work is significant since closed-loop tACS will enable the investigation of the causal role of specific circuit dynamics in humans and the development of novel treatments for depression which are urgently needed.

项目总结- Pulvinar Neuro LLC，汤森 由于缺乏工具，人们对回路活动动态在抑郁症中的因果作用仍然知之甚少 非侵入性的有针对性的电路调制。今天的非侵入性脑刺激方法适用于通用的 刺激波形，而不以个体活动特征为目标并且不动态地适应 刺激大脑活动的持续波动。为了解决这一差距，Pulvinar Neuro的长期目标是 开发、评估和商业化靶向闭环经颅交流电刺激（tACS） 该技术通过EEG测量大脑活动，并动态地将弱节律电场应用于 调制网络振荡。在之前的第1阶段SBIR中，Pulvinar Neuro开发了XCSITE 100 Pro， 闭环tACS设备，成功地测试了健康人类参与者的可行性，以及XCSITE 200，用于远程刺激的基于云的平台。该应用程序的总体目标是开发和评估 XCSITE 300平台将闭环功能与基于云的模拟和研究相结合 管理该项目的基本原理是，这样的解决方案将推动下一代基于电路的 精神病学的研究，闭环tACS有可能成为一种安全有效的治疗方法， 考虑到开环tACS治疗抑郁症的初步积极结果， 未满足的市场需求。为实现这一目标，将努力实现三个具体目标。(1)集成和台架测试 采用基于云的基础设施的闭环tACS技术，（2）在试验中测试XCSITE 300以供实验室内使用 抑郁症治疗的双盲单中心研究（XCSITE 300 Clinic），以及（3）Adapt器械形式 因素和用户界面在家里使用（XCSITE 300家庭），并建立在人的试点研究的可行性 抑郁症在拟议工作完成后，闭环tACS的可行性和初步功效将 建立和闭环tACS用于在诊所和在家里使用的患者将准备关键 治疗抑郁症的研究。在这个应用程序中的工作是创新的缺乏可用的 用于探测电路动力学和用于评估临床诊断的云使能（“智能”）闭环tACS设备 在严格的双盲试验中的有效性。拟议的工作是重要的，因为闭环tACS将使 研究人类特定回路动力学的因果作用和开发新的治疗方法 治疗抑郁症的药物