Assessing the feasibility and acceptability of using non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) to reduce PTSD symptoms in WTC responders

评估使用非侵入性经皮耳迷走神经刺激 (taVNS) 来减少 WTC 应答者 PTSD 症状的可行性和可接受性

• 批准号: 10313676
• 负责人: Rebecca Schwartz
• 金额: $ 34.99万
• 依托单位: FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-07-01 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10313676
• 关键词: Assessing; feasibility; acceptability; using; non

ABSTRACT Posttraumatic Stress Disorder (PTSD) remains the most prevalent mental health (MH) diagnosis for first responders involved with responding to the 9/11 World Trade Center (WTC) terrorist attacks, with rates of PTSD much higher than that of the general population. There are a number of evidence-based treatments (EBT) for PTSD, with the strongest evidence base for trauma focused therapies, which typically require that patients engage with the index trauma and the associated fears and cognitions. This can be particularly difficult for PTSD patients for whom avoidance is a key symptom. Although these treatments are well supported, they are less effective in military and veteran populations in particular. Additionally, high dropout rates are observed across treatments for PTSD, with some studies yielding dropout rates of over 30%. Given the high rates of PTSD and the lower uptake of effective PTSD treatment among responders, there is a clear need to provide brief, easily accessible treatments to WTC responders to alleviate PTSD symptoms. There is a growing body of literature to support the use of vagus nerve stimulation (VNS) to treat a number of different disorders with promising animal model research regarding the use of VNS to address some of the features of PTSD, specifically, due to the impact that VNS has on key areas of the brain that are associated with fear extinction and hyperarousal in particular. The current study aims to determine whether the use of a novel, safe, non- invasive form of VNS, transcutaneous auricular VNS (taVNS), would be acceptable and feasible for use with WTC responders who have PTSD, and whether the methodology involved with a larger randomized controlled trial (RCT) to test taVNS efficacy would be acceptable and feasible. As such, the current study involves conducting a formative phase evaluation in the context of a focus group with WTC responders with elevated PTSD symptoms, in order to tailor the taVNS intervention and the pilot study methodology so that it’s relevant and acceptable for use. The taVNS intervention will then be piloted in a randomized, double-blind placebo controlled parallel-design study with 30 WTC responders affiliated with the Northwell Queens WTC Health Program who have PTSD. Outcomes include taVNS intervention and study methodology feasibility and acceptability. In addition, differences between baseline and post-treatment MH measures will be used to generate hypotheses for a future larger RCT aimed at evaluating taVNS efficacy in PTSD symptom reduction among a larger sample of WTC responders with PTSD. We will also use results to generate hypotheses regarding potential mechanisms of action including the various inflammatory, neural and cardiovascular changes that correlate with treatment outcomes. This pilot feasibility study is a first step toward bringing the latest advances in non-invasive, easy to use bioelectronic medicine technology to a population with high rates of PTSD who experience barriers to treatment engagement and adherence.

抽象的 创伤后应激障碍 (PTSD) 仍然是最常见的心理健康 (MH) 诊断 参与应对 9/11 世界贸易中心 (WTC) 恐怖袭击的响应人员，其比率为 创伤后应激障碍（PTSD）远高于一般人群，有许多基于证据的治疗方法。 (EBT) 治疗创伤后应激障碍 (PTSD)，具有针对创伤重点治疗的最强有力的证据基础，通常需要 患者遭受索引创伤以及相关的恐惧和认知，这可能特别困难。 对于以回避为关键症状的创伤后应激障碍 (PTSD) 患者来说，尽管这些治疗方法得到了充分支持，但它们的效果并不理想。 尤其是在军人和退伍军人群体中效果较差。此外，还观察到较高的辍学率。 鉴于 PTSD 的高比例，一些研究得出的退出率超过 30%。 PTSD 以及应答者对有效 PTSD 治疗的接受率较低，因此显然需要提供 世贸中心响应者可以使用简单、容易获得的治疗来缓解创伤后应激障碍 (PTSD) 症状。 支持使用迷走神经刺激 (VNS) 治疗多种不同疾病的文献 关于使用 VNS 来解决 PTSD 某些特征的动物模型研究， 具体来说，由于迷走神经刺激对大脑中与恐惧消退相关的关键区域产生影响 当前的研究旨在确定是否使用一种新颖的、安全的、非兴奋性的药物。 侵入性 VNS，即经皮耳道 VNS (taVNS)，与以下药物一起使用是可以接受且可行的： 患有 PTSD 的 WTC 响应者，以及该方法是否涉及更大的随机对照 测试 taVNS 疗效的试验（RCT）是可接受且可行的，因此，当前的研究涉及。 在焦点小组的背景下与世贸中心响应者进行形成阶段评估 PTSD 症状，以便调整 taVNS 干预和试点研究方法，使其具有相关性 然后，taVNS 干预措施将在随机、双盲安慰剂中进行试点。 对隶属于 Northwell Queens WTC Health 的 30 名 WTC 响应者进行的对照平行设计研究 患有 PTSD 的计划成果包括 taVNS 干预和研究方法的可行性和 此外，基线和治疗后 MH 测量之间的差异将用于评估。 为未来更大的随机对照试验提出假设，旨在评估 taVNS 在减轻 PTSD 症状方面的功效 我们还将使用结果来生成假设。 关于潜在的作用机制，包括各种炎症、神经和心血管 这项试点可行性研究是实现这一目标的第一步。 非侵入性、易于使用的生物电子医学技术的最新进展，适用于高发病率人群 PTSD 患者在参与治疗和坚持治疗方面遇到障碍。