Pilot Testing of Theta-Burst Neuromodulation for Chronic PTSD

 描述（由申请人提供）： 创伤后应激障碍（PTSD）是一种高度流行的慢性精神疾病，它造成了重大的健康负担，与明显的职业和社会功能障碍有关，并伴有严重的精神和医学共病。尽管它的流行和破坏性的影响，现有的治疗创伤后应激障碍已被发现是不太有效的退伍军人与创伤后应激障碍。基于证据的药物治疗和心理治疗方法在改善这一人群的症状和功能方面取得了一定的成功，这是由于耐受性和最大疗效方面的限制。因此，创伤后应激障碍的治疗创新的干预措施是迫切需要的退伍军人与创伤后应激障碍。 非侵入性神经调节技术的应用正在神经精神病学中迅速发展。新设备的可用性，加上对与精神疾病相关的潜在神经回路的了解增加，为经济上有利的和创新的PTSD治疗技术的临床应用奠定了基础。有一个既定的文献，支持非侵入性神经调节治疗抑郁症的疗效，虽然这种方法治疗PTSD的兴奋已经被漫长的管理时间和缺乏数据的PTSD症状的变化是否发生在生活质量或社会和职业功能的变化。 拟议研究的目的是检查间歇性θ-爆发刺激（iTBS）作为退伍军人PTSD干预的潜力。TBS对创伤后应激障碍有着特殊的希望，因为它可以快速传递大量的刺激，而且它的模式传递可能特别影响大脑的关键区域。 创伤后应激障碍这项研究的一个重要焦点是评估生活质量和功能的变化是否随TBS引起的PTSD症状严重程度的变化而变化。为此，我们建议对55名患有PTSD的退伍军人进行一项试点研究，随机接受TBS或假手术，有三个具体目的：1）确定招募和随机化的可行性，2）确定TBS的可接受性，3）提供iTBS对症状变化以及功能结局影响的初步证据。 该项目将为随后的随机对照试验奠定可行性，可接受性和方法学的基础，具有足够的统计能力来测试辅助TBS治疗PTSD的疗效和提高PTSD退伍军人的生活质量。该项目的长期意义在于对创伤后应激障碍实施TBS及其与心理治疗的结合，为创伤后应激障碍退伍军人创造一个强大的，个性化的康复选择。

 DESCRIPTION (provided by applicant): Posttraumatic Stress Disorder (PTSD) is a highly prevalent, chronic psychiatric disorder that imposes a major health burden, is associated with marked occupational and social dysfunction, and occurs with significant high degrees of psychiatric and medical comorbidity. Despite its prevalence and devastating impact, available treatments for PTSD have been found to be less effective for Veterans with PTSD. Evidence based pharmacotherapy and psychotherapy approaches have had modest success in improving symptoms and function in this population due to limitations both in terms of tolerability and maximal efficacy. Therefore, innovative interventions for the treatment of PTSD are sorely needed for Veterans with PTSD. The application of non-invasive neuromodulation technologies is developing rapidly across neuropsychiatry. The availability of new devices, coupled with increased knowledge of underlying neurocircuitry relevant to psychiatric illness, sets the stage for economically advantageous and innovative clinical applications of technologies for PTSD treatment. There is an established body of literature that supports the efficacy of non-invasive neuromodulation for treatment of depression, although excitement for this approach for PTSD has been tempered by lengthy administration times and a paucity of data on whether changes in PTSD symptoms occur alongside changes in quality of life or social and occupational function. The aim of the proposed research is to examine the potential of intermittent theta-burst stimulation (iTBS) as an intervention for PTSD in Veterans. TBS holds particular promise for PTSD as can deliver a large number of stimulations rapidly, and its pattered delivery may particularly affect key brain regions involved in PTSD. An important focus of this research is evaluating whether changes in quality of life and function vary with changes in PTSD symptom severity due to TBS. To this end, we propose to conduct a pilot study of 55 Veterans with PTSD randomized to receive either TBS or sham, with three Specific Aims: 1) determine the feasibility of recruitment and randomization, 2) determine the acceptability of TBS, and 3) to provide preliminary evidence of the effects of iTBS on changes in symptoms alongside functional outcomes. This project will lay the groundwork in terms of feasibility, acceptability and methodology for a subsequent randomized controlled trial with adequate statistical power to test both the efficacy of adjunct TBS for PTSD and increasing quality of life for Veterans with PTSD. The longer-term significance of this project lies in the potential for implementing TBS for PTSD and its combination with psychotherapy, to create a powerful, individualized rehabilitation option for Veterans with PTSD.