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

用于治疗 SUD 的更高功率 tACS 装置的开发和评估

• 批准号: 10325051
• 负责人: Leah Bishop Townsend
• 金额: $ 31.9万
• 依托单位: PULVINAR NEURO LLC
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-01 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10325051
• 关键词: Abstinence; Address; Behavior Therapy; Behavioral; Biological Assay; Brain Diseases; Charge; Clinical; Clinical Treatment; Clinical Trials; Computer software; Data; Daughter; Development; Devices; Dose; Double-Blind Method; Ensure; Equipment; Evaluation; Future; Goals; Gold; Grant; Histologic; Human; Human Resources; Investigation; Ions; Lithium; Membrane; Modality; Modification; Neurons; Outcome; Output; Participant; Patients; Performance; Pharmacology; Phase; Pilot Projects; Placebos; Population; Pulvinar structure; Rattus; Relapse; Reporting; Research; Research Design; Safety; Scalp structure; Short Interspersed Nucleotide Elements; Source; Specific qualifier value; Substance Use Disorder; Technology; Testing; Therapeutic; Therapeutic Effect; Work; awake; base; clinical development; density; dosage; drug of abuse; efficacy study; electric impedance; experience; in vivo; innovation; neural circuit; neurophysiology; next generation; noninvasive brain stimulation; novel; novel therapeutic intervention; patient population; phase 2 study; placebo controlled study; pre-clinical; preclinical study; product development; substance use treatment; voltage

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.

项目总结- 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。 在这里，我们建议通过开发XCSITE HPtACS来解决这一差距，XCSITE HPtACS是一种基于 在我们现有的XCSITE平台上，实现金标准、双盲、安慰剂对照研究设计。 在本提案中，我们将完成对现有XCSITE 100设备的修改， 持续治疗效果所需的振幅刺激。我们将评估其性能和安全性 在评价更高振幅的可行性和耐受性之前， 在SUD患者的初步研究中进行刺激。第一阶段资助的目标是推进产品 开发和测试，以便在申请FDA之前为进一步的临床开发做好准备 用于治疗SUD。Pulvinar Neuro拥有成功的开发记录， 将移动的神经生理学研究设备商业化。在未来的第二阶段研究中，我们计划进行 评估XCSITE HPtACS作为SUD治疗剂的疗效的初始治疗临床试验。