Empower Neuromodulation System, a home-use device for the treatment of anxiety disorders

Empower Neuromodulation System，一种治疗焦虑症的家用设备

• 批准号: 10266674
• 负责人: Daniel Rogers Burnett
• 金额: $ 30.3万
• 依托单位: THERANOVA, LLC
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-05-15 至 2023-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10266674
• 关键词: Acupuncture Points; Acupuncture Therapy; Address; Adherence; Adoption; Adult; Adverse event; Affect; American; Animals; Anti-Anxiety Agents; Anxiety; Anxiety Disorders; Behavior; Benzodiazepines; Blinded; COVID-19 pandemic; Censuses; Chronic; Clinic; Clinical Research; Clinical Trials; Cognitive Therapy; Controlled Clinical Trials; Data; Dependence; Development; Devices; Disease remission; Double-Blind Method; Effectiveness; Electroacupuncture; Electrodes; Financial cost; Future; Gel; Generalized Anxiety Disorder; Goals; Guidelines; Home; Human; Investigation; Measures; Medical Care Costs; Medical Device; Morphine; Muscle; Nerve; PC6 extract; Participant; Pathway interactions; Patients; Peripheral Nerve Stimulation; Pharmaceutical Preparations; Phase; Placebos; Prevalence; Randomized; Reporting; Rodent Model; Safety; Selective Serotonin Reuptake Inhibitor; Self Administration; Signal Transduction; Site; Skin; Small Business Innovation Research Grant; Structure of ulnar nerve; Surveys; Symptoms; System; Transcutaneous Electric Nerve Stimulation; Treatment Protocols; Visit; Withdrawal; Work; Wrist; acceptability and feasibility; active method; alcohol use disorder; anxiety reduction; base; biceps brachii muscle; commercialization; cost; effective therapy; excessive anxiety; median nerve; neuroregulation; pandemic disease; portability; preclinical study; repetitive transcranial magnetic stimulation; research clinical testing; satisfaction; sham-controlled study; side effect; treatment group; treatment of anxiety disorders; usability

Abstract Generalized anxiety disorder (GAD) is a chronic, recurring condition that affects approximately 6.4 million American adults each year. GAD is one of the most common anxiety disorders and is costly to treat, with medical costs that are 33% higher than other anxiety disorders. Recent weekly GAD-2 surveys by the U.S. Census Bureau have indicated that the prevalence of GAD may be sharply increasing as a result of the COVID-19 pandemic. As of July 2020, 36% of American adults have symptoms of GAD vs. 8% before the pandemic. Taken together, there is a need for a comprehensive therapy to effectively treat GAD. First-line treatments for GAD include medication (e.g. SSRIs, SNRIs), cognitive behavioral therapy, or both in combination. Unfortunately, these all have shown modest long-term remission rates of only 20-50%. Medications also have common, undesirable side effects that limit acceptability to patients. Benzodiazepines (BZs) are the most effective medication for treating GAD. However, guidelines recommend only prescribing BZs for short-term use due to the potential to develop tolerance and dependence. Neuromodulation investigations via repetitive transcranial magnetic stimulation (rTMS) have recently shown great promise for treating GAD, with responder rates of 64- 100% in short-term studies. However, rTMS is expensive ($6,000-$12,000 for a 20-30 treatment course) and requires daily visits to the clinic, limiting the potential for widespread adoption. Recent preclinical and clinical studies have also shown that acupuncture-based nerve stimulation can be effective for treating anxiety, but it has the key limitation that treatment must be administered by an acupuncturist in the clinic or at home. To build on this work and address the need for a comprehensive therapy for GAD, TheraNova has developed the Empower Neuromodulation System, a portable, non-invasive transcutaneous electrical nerve stimulation (TENS), or transcutaneous electroacupuncture, device for non-invasive stimulation of peripheral nerves. The Empower Neuromodulation System consists of standard, inexpensive TENS gel electrodes and a small, battery- powered signal generator. The goal of this proposal is to conduct a pilot clinical study to evaluate the potential of Empower as a treatment for GAD. We will conduct a 6-week, sham-controlled study in 30 participants with GAD. Participants will be randomized (1:1) to the active or sham treatment and self-administer treatment at home for the duration of the study. In this single study, we will evaluate metrics of feasibility (Specific Aim 1) and acceptability (Specific Aim 2). After demonstrating feasibility in Phase I, we will conduct a long-term pivotal clinical trial in Phase II to evaluate the effect of the Empower therapy on GAD remission. This pivotal study will support FDA clearance, enabling commercialization after Phase II.

抽象的 广泛性焦虑症 (GAD) 是一种慢性、反复发作的疾病，影响约 640 万人 每年美国成年人。 GAD 是最常见的焦虑症之一，治疗费用昂贵，需要药物治疗 其费用比其他焦虑症高出 33%。美国人口普查局最近进行的每周 GAD-2 调查 局表示，由于 COVID-19，广泛性焦虑症 (GAD) 的患病率可能急剧上升 大流行。截至 2020 年 7 月，36% 的美国成年人有广泛性焦虑症症状，而疫情爆发前这一比例为 8%。采取 总之，需要一种综合疗法来有效治疗广泛性焦虑症。 GAD 的一线治疗 包括药物治疗（例如 SSRIs、SNRIs）、认知行为治疗或两者的组合。很遗憾， 这些都显示出只有 20-50% 的适度长期缓解率。药物也有共同点， 不良副作用限制了患者的可接受性。苯二氮卓类 (BZ) 是最有效的 治疗广泛性焦虑症的药物。然而，指南建议仅短期使用 BZ，因为 发展耐受性和依赖性的潜力。通过重复经颅神经调节研究 磁刺激 (rTMS) 最近在治疗广泛性焦虑症 (GAD) 方面显示出巨大的前景，应答率为 64- 100%短期学习。然而，rTMS 价格昂贵（20-30 个疗程需 6,000-12,000 美元） 需要每天去诊所就诊，限制了广泛采用的潜力。最近的临床前和临床 研究还表明，基于针灸的神经刺激可以有效治疗焦虑症，但它 其主要限制是治疗必须由针灸师在诊所或家中进行。建造 在这项工作的基础上，为了满足广泛性焦虑症 (GAD) 综合治疗的需求，TheraNova 开发了 Empower Neuromodulation System，一种便携式、非侵入性经皮神经电刺激 （TENS）或经皮电针，用于非侵入性刺激周围神经的装置。这 Empower 神经调节系统由标准、廉价的 TENS 凝胶电极和一个小型电池组成 供电信号发生器。该提案的目标是进行一项试点临床研究以评估潜在的 Empower 作为广泛性焦虑症 (GAD) 的治疗方法。我们将对 30 名参与者进行为期 6 周的假对照研究 GAD。参与者将被随机 (1:1) 接受主动治疗或假治疗，并在家自行进行治疗 在研究期间。在这项研究中，我们将评估可行性指标（具体目标 1）和 可接受性（具体目标 2）。在第一阶段论证可行性后，我们将进行长期关键的研究 II 期临床试验评估 Empower 疗法对 GAD 缓解的效果。这项关键研究将 支持 FDA 批准，以便在 II 期后实现商业化。