Development and Evaluation of a Higher Power tACS Device for the Treatment of SUD

项目摘要-汤森德垫状神经有限责任公司 物质使用障碍(SUD)是一种非常普遍但难以治疗的大脑疾病(Wise等人，2014； McLellan等人，2000年)。虽然临床医生有一系列的药物和行为干预措施 可用于治疗sud，未得到满足的需求仍然居高不下，无论滥用药物有12个月 复发率为40%-60%(Klein，2016；McLellan等人，2000)。经颅交流电刺激 (Tacs)代表了一种治疗SUD的新方法，最近一项关于SUD中Tacs的研究 显示出有希望的初步结果(Daughters等人，2020年)。然而，从短期的、瞬间的 刺激对长时间治疗性回路调制的影响需要更广泛的Tacs范式 比目前使用现有技术所能达到的目标更高。 在这里，我们建议通过开发XCSITE HPtACS来解决这一差距，XCSITE HPtACS是一款基于TACS的高性能设备 在我们现有的XCSITE平台上，该平台支持黄金标准、双盲、安慰剂对照研究设计。 在本计划中，我们将完成对现有XCSITE 100设备的修改，以实现更高的 持久的治疗效果所需的幅度刺激。我们将对其性能和安全性进行评估 在评估更高幅度的可行性和耐受性之前，该设备在临床前大鼠研究中的应用 SUD患者的一项先导性研究中的刺激。这一阶段第一阶段资助的目标是促进产品 在寻求FDA之前为进一步的临床开发做好设备的开发和测试 为SUD的治疗提供许可。枕神经研制成功的记录和 将移动神经生理学研究设备商业化。在未来的第二阶段研究中，我们计划执行 一项评估XCSITE HPtACS治疗SUD疗效的初步临床试验。

PROJECT SUMMARY – Pulvinar Neuro LLC, TOWNSEND Substance use disorder (SUD) is a highly prevalent but difficult to treat brain disorder (Wise et al., 2014; McLellan et al., 2000). While clinicians have a range of a range of pharmacologic and behavioral interventions available for the treatment of SUD, unmet need remains high regardless of drug of abuse with 12-month relapse rates of 40-60% (Klein, 2016; McLellan et al., 2000). Transcranial alternating current stimulation (tACS) represents a novel therapeutic approach for the treatment of SUD with a recent study of tACS in SUD showing promising initial results (Daughters et al., 2020). However, shifting from short-term, instantaneous effects of stimulation to long-lasting, therapeutic circuit modulation requires more extensive tACS paradigms than can currently be achieved with existing technology. Here, we propose to address this gap by developing XCSITE HPtACS, a high-powered tACS device based on our existing XCSITE platform that enables gold-standard, double-blind, placebo-controlled study designs. In this proposal, we will complete modifications to our existing XCSITE 100 device to enable the higher amplitude stimulation required for a durable therapeutic effect. We will evaluate the performance and safety of the device in a preclinical rat study before evaluating feasibility and tolerability of higher amplitude stimulation in a pilot study of patients with SUD. The goal of this Phase 1 grant is to advance product development and testing to prepare the device for further clinical development ahead of seeking FDA clearance for the treatment of SUD. Pulvinar Neuro has successful track-record of developing and commercializing mobile neurophysiology research equipment. In a future Phase 2 study, we plan to perform an initial treatment clinical trial to assess the efficacy of XCSITE HPtACS as a therapeutic for SUD.