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

项目摘要-汤森德垫状神经有限责任公司 由于缺乏工具，回路活动动力学在抑郁症中的因果作用仍然知之甚少。 非侵入性、有针对性的电路调制。今天的非侵入性脑刺激方法适用于普通 不以个体活动特征为目标且不动态适应的刺激波形 刺激大脑活动的持续波动。为了解决这一差距，脑枕的长期目标是 开发、评估和商业化定向闭环式经颅交流电刺激(TACS) 这项技术用脑电测量大脑活动，并动态地将弱节奏电场应用于 调节网络振荡。在之前的第一阶段SBIR中，枕神经开发了XCSITE 100Pro，一个 成功在健康人体参与者中测试可行性的闭环式TACS设备，以及XCSITE 200，一个基于云的远程刺激平台。这个应用程序的总体目标是开发和评估 将闭环功能与基于云的刺激和研究相结合的XCSITE 300平台 管理层。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 精神病学和闭环式TACS的研究有可能成为一种安全有效的治疗方法 抑郁症患者给予开环Tacs治疗抑郁症的初步阳性发现和实质性 未得到满足的市场需求。为实现这一目标，将追求三个具体目标。(1)集成测试和台架测试 采用基于云的基础架构的闭环TACS技术，(2)测试XCSITE 300以便在实验室内进行试点使用 抑郁症治疗的双盲单点研究(XCSITE 300临床)；(3)适配装置形式 家庭使用的因素和用户界面(XCSITE 300 Home)，并在人的试点研究中建立可行性 患有抑郁症。在拟议的工作完成后，闭环系统的可行性和初步效果将 将建立用于临床和患者在家使用的闭环式TAC，并为Pivotal 抑郁症的治疗研究。这个应用程序中的工作是创新的，因为缺乏可用的 用于探测电路动力学和临床评估的云使能(智能)闭环式TACS设备 在严格的双盲试验中的疗效。拟议的工作意义重大，因为闭环式TAC将使 人类特定回路动力学因果作用的研究和新治疗方法的开发 对于迫切需要的抑郁症。

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.