Stellate Ganglion Blockade for the Management of Vasomotor Symptoms

星状神经节阻滞治疗血管舒缩症状

• 批准号: 9895591
• 负责人: DAVID R WALEGA
• 金额: $ 64.57万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-08-01 至 2022-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9895591
• 关键词: Affect; Aftercare; Ambulatory Monitoring; Amygdaloid structure; Anatomy; Anterior; Anxiety; Area; Blood Vessels; Brain; Brain region; Bupivacaine; Cervical spine; Clinical Trials; Controlled Clinical Trials; Effectiveness; Emotions; Fluoroscopy; Foundations; Frequencies; Galvanic Skin Response; Ganglia; Hippocampus (Brain); Hormone use; Hot flushes; Hyperhidrosis disorder; Injections; Insula of Reil; Intervention; Intervention Studies; Ipsilateral; Local Anesthetics; Measures; Memory; Menopause; Monitor; Moods; Neck; Nerve; Nervous System Physiology; Neuropathy; Night Sweating; Outcome; Pain management; Paroxetine; Participant; Patient Self-Report; Performance; Physiological; Placebos; Postmenopause; Prefrontal Cortex; Productivity; Publishing; Quality of life; Randomized; Relapse; Reporting; Research; Rest; Safety; Saline; Selective Serotonin Reuptake Inhibitor; Serious Adverse Event; Site; Skin; Sleep; Sleep disturbances; Structure; Structure of stellate ganglion; Subcutaneous Tissue; Sympathetic Nervous System; Symptoms; Techniques; Telemetry; Tissues; United States; United States Food and Drug Administration; Vascular Diseases; Vasomotor; Woman; Women' s Health; Work; affective disturbance; anxiety symptoms; arm; associated symptom; cognitive function; depressive symptoms; experience; hormone therapy; improved; innovation; neural circuit; neuroimaging; novel strategies; open label; painful neuropathy; public health relevance; relating to nervous system; secondary analysis; secondary outcome; side effect; sleep quality; support network; symptom treatment; treatment effect; trend

 DESCRIPTION (provided by applicant): The overall aim of this randomized, sham-controlled clinical trial is to demonstrate that stellate ganglion block (SGB) is an effective and safe non-hormonal intervention for women seeking relief from vasomotor symptoms (VMS) and to identify the physiologic mechanisms underlying this treatment effect. More than 50% of women experience frequent hot flashes and night sweats (i.e., VMS), and these symptoms last on average 7.4 years. VMS are associated with decreased quality of life, increased depressive and anxiety symptoms, sleep disturbance, memory difficulties, and reduced productivity. Safety concerns raised in the Women's Health Initiative (WHI) led to an 80% decline in the use of hormone therapy in the United States. Identifying safe and effective non-hormonal treatments for VMS remains a priority in women's health research. The stellate ganglion, a sympathetic neural structure in the deep tissues of the neck, is commonly blocked with local anesthetics in the treatment of neuropathic and vascular disorders. In open-label intervention studies SGB with local anesthetic reduced VMS by 34 to 90% four weeks to several months after treatment. We conducted the first randomized, sham-controlled (injection of saline into subcutaneous tissue in the neck) trial of SGB (with 0.5% bupivacaine 5 mL) for the treatment of VMS in menopausal women with moderate to very severe VMS (n = 40). A single SGB with local anesthetic significantly reduced moderate-to-very severe VMS by 50% more than sham treatment and lasted for up to sixth months. Analyses of secondary outcomes revealed significant improvements in objectively-measured VMS and trends (p < .10) for improvements in depressive symptoms and memory performance with active SGB compared to sham intervention. In this proposal, we aim to conduct a randomized, sham-controlled clinical trial to more definitively assess the effects of SGB on VMS and to conduct foundational studies to identify the mechanisms of SGB action. The clinical trial will include 220 menopausal women who report 28 or more weekly VMS. Secondary outcomes will include objectively- measured VMS, mood and anxiety, quality of life, sleep, and memory performance. After an initial baseline assessment, women will be reassessed at 3 and 6 months following the SGB or sham intervention. In a subset of 60 women (30 per arm), we will perform a nested, mechanistic substudy built on foundational work in neuroimaging of VMS and ambulatory monitoring of sympathetic nerve activity and telemetry. These two mechanistic outcomes will be obtained at baseline and at 3 months following the intervention. We predict that compared to sham intervention, SGB will reduce the frequency of VMS, improve mood and anxiety, increase quality of life, and improve memory, reduce efferent sympathetic nerve activity and normalize brain activity in thermoregulatory brain areas but have no effect on sleep or other cognitive functions. By providing a more definitive understanding of the effectiveness of SGB, possible secondary benefits, and mechanisms of action, these findings will fill a critical gap in treatment options available to women.

 描述(申请人提供)：这项随机、假对照临床试验的总体目标是证明星状神经节阻滞(SGB)对于寻求缓解血管运动症状(VMS)的女性是一种有效和安全的非激素干预，并确定这种治疗效果的生理机制。超过50%的女性经历了频繁的潮热和盗汗(即VMS)，这些症状平均持续7.4年。VMS与生活质量下降、抑郁和焦虑症状增加、睡眠障碍、记忆困难和生产力下降有关。妇女健康倡议(WHI)中提出的安全问题导致美国激素疗法的使用减少了80%。寻找安全有效的非激素治疗VMS仍然是妇女健康研究的优先事项。星状神经节是颈部深层组织中的一种交感神经结构，在治疗神经性和血管疾病时，常被局麻药阻断。在开放标签干预研究中，使用局麻药的SGB在治疗后四周至几个月内将VMS减少了34%至90%。我们进行了第一次随机、假对照(颈部皮下注射生理盐水)试验，SGB(含0.5%布比卡因5毫升)用于治疗患有中度至极重度VMS的绝经妇女(n=40)。与假治疗相比，单独使用局部麻醉剂的SGB显着减少了中到极重度VMS的50%，并持续了长达6个月。对二次结果的分析显示，与假干预相比，主动SGB组在客观测量的VMS和改善抑郁症状和记忆表现方面的趋势(p&lt；.10)有显著改善。在这项建议中，我们的目标是进行一项随机、假对照的临床试验，以更明确地评估SGB对VMS的影响，并进行基础研究，以确定SGB的作用机制。这项临床试验将包括220名更年期妇女，她们每周报告28例或更多VMS。次要结果将包括客观测量的VMS、情绪和焦虑、生活质量、睡眠和记忆表现。在最初的基线评估之后，妇女将在接受SGB或假干预后的3个月和6个月重新评估。在60名女性(每只手臂30名)的子组中，我们将进行一项嵌套的机械性亚研究，建立在VMS的神经成像以及交感神经活动和遥测的动态监测的基础工作基础上。这两个机械性结果将在基线和干预后3个月获得。我们预测，与假干预相比，SGB可以减少VMS的发生频率，改善情绪和焦虑，提高生活质量，改善记忆，减少传出交感神经活动，使大脑温度调节区域的活动正常化，但对睡眠或其他认知功能没有影响。通过更明确地了解SGB的有效性、可能的次要好处和行动机制，这些发现将填补妇女可用治疗选择方面的一个关键空白。