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

项目摘要- Pulvinar Neuro LLC，汤森 物质使用障碍（SUD）是一种高度流行但难以治疗的脑部障碍（Wise等人，二〇一四年 McLellan等人，2000年）。虽然临床医生有一系列的药理学和行为干预措施， 可用于治疗SUD，未满足的需求仍然很高，无论药物滥用12个月 复发率为40-60%（Klein，2016; McLellan等人，2000年）。经颅交流电刺激 最近一项关于tACS治疗SUD的研究表明，tACS是治疗SUD的一种新方法 显示出有希望的初步结果（Daughters等人，2020年）。然而，从短期的，瞬时的 刺激对持久治疗回路调制的影响需要更广泛的tACS范例 比现有技术所能达到的还要多。 在同品种I期SBIR项目中，我们通过开发XCSITE HPtACS（一种高性能 tACS设备基于我们现有的XCSITE平台，能够实现金标准，双盲，安慰剂， 对照研究设计。在这个项目中，我们将完成对现有XCSITE 100设备的修改， 能够实现持久治疗效果所需的更高幅度的刺激。我们将评估 在评价可行性和耐受性之前，在临床前大鼠研究中评估器械的性能和安全性 在SUD患者的初步研究中进行更高幅度的刺激。同品种医疗器械第1阶段资助的目标是 推进产品开发和测试，为器械的进一步临床开发做好准备 寻求FDA批准治疗SUD。Pulvinar Neuro在开发 和商业化的移动的神经生理学研究设备。在未来的第二阶段研究中，我们计划 进行初始治疗临床试验，以评估XCSITE HPtACS作为SUD治疗剂的疗效。

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. In the predicate Phase I SBIR project, we 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 project, 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 the predicate 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.