Delivery of an At-Home Nonpharmacologic Intervention (Transcranial Neurostimulation) to Mitigate Pain in Patients with End Stage Kidney Disease Receiving Hemodialysis

项目摘要 在美国，超过50万名终末期肾病（ESKD）患者接受慢性血液透析（HD）。 美国每年. ESKD/HD的患病率正在增加，特别是在少数种族/族裔中。有 迫切需要解决ESKD/HD患者经常面临的许多临床问题。一个最 最紧迫的问题是疼痛管理不善。疼痛影响高达90%的ESKD/HD患者;影响情绪， 功能和整体生活质量（QoL）。药物治疗仍然是最常见的方法， 治疗疼痛和大量ESKD/HD患者继续接受长期阿片类药物治疗。 这种管理疼痛的方法受到不良后果的实质性风险的限制，包括福尔斯、骨折， 和住院治疗。需要新的非药物疗法来减轻疼痛并减少对阿片类药物治疗的依赖 在患者人群中。鉴于ESKD/HD在有色人种中的患病率日益增加， 研究严格评估了新疗法在少数群体中的安全性和有效性。 经颅直流电刺激（tDCS）是一种非侵入性神经调节疗法，称为 具有最小的风险，可以减少不同类型慢性疼痛患者的疼痛和镇痛药消耗， 痛苦以前的随机对照试验（RCT）受到样本量小和刺激的限制 简短（≤10个疗程）、未采用家庭刺激功能且仅 评估短期影响，即，大多采用4周或更短时间的干预后随访。 据我们所知，没有tDCS镇痛试验评估长期治疗结果或确定 治疗效果是否随人种/种族状态而变化。 我们来自纽约州威尔康奈尔医学/康奈尔大学的经验丰富的多学科研究团队， 纽约州罗戈辛研究所和大都会犹太医疗保健系统（MJHS）创新研究所， 纽约姑息治疗开创了一种在家远程监督的tDCS远程医疗方法， 长期刺激方案适用于患有严重慢性疾病（如ESKD/HD）的人群。我们 建议进行充分把握度的RCT（N=100），确保入组的患者数量大致相等 西班牙裔，非西班牙裔黑人和非西班牙裔白人的数量，目的如下：1）确定 短期（在2周和40次8周tDCS方案结束时）和长期（12，16 和基线后26周）在家tDCS相对于假刺激对疼痛的影响（主要结局）， 镇痛药消耗、疼痛干预、抑郁情绪和生活质量（次要结局）; 2） 评估tDCS对结局的影响是否因人种/种族而异;以及3）确定tDCS在以下人群中的耐受性： 副作用术语，并评估患者对器械使用和研究程序的满意度。家庭tDCS是一种 非常有前途的ESKD/HD疼痛非药物治疗。确定其长期影响可以 改变在这个种族多样化的不断增长的患者群体中管理疼痛的方式。

PROJECT SUMMARY More than 500,000 patients with end-stage kidney disease (ESKD) receive chronic hemodialysis (HD) in the U.S. each year. The prevalence of ESKD/HD is increasing, particularly among racial/ethnic minorities. There is a compelling need to address the many clinical concerns that ESKD/HD patients routinely face. One of the most pressing concerns is poorly managed pain. Pain affects up to 90% of ESKD/HD patients; compromising mood, functioning, and overall quality of life (QoL). Pharmacotherapy remains the most common approach to managing pain and substantial numbers of ESKD/HD patients continue to receive long-term opioid treatment. This approach to managing pain is limited by substantial risks of adverse outcomes, including falls, fractures, and hospitalization. Novel non-drug therapies are needed to reduce pain and lessen reliance on opioid therapy in the patient population. Given the increasing prevalence of ESKD/HD in persons of color, it is essential that studies evaluate rigorously the safety and efficacy of new treatments in minority populations. Transcranial direct current stimulation (tDCS) is a non-invasive neuromodulatory therapy, designated as having minimal risk that can reduce pain and analgesic consumption in patients with diverse types of chronic pain. Previous randomized controlled trials (RCTs) have been limited by small sample sizes and stimulation protocols that are brief (≤10 sessions), have not employed at-home stimulation capability, and have only assessed for short-term effects, i.e., mostly employed post-intervention follow-ups of 4 weeks or less. To the best of our knowledge, no tDCS analgesic trial has evaluated longer-term treatment outcomes or determined whether treatment effects vary as a function of race/ethnicity status. Our highly experienced multidisciplinary research team from Weill Cornell Medicine/Cornell University, NY, the Rogosin Institute, NY, and the Metropolitan Jewish Healthcare System (MJHS) Institute for Innovation in Palliative Care, NY has pioneered an at-home, remotely supervised tDCS-telehealth approach that enables long-term stimulation protocols suitable for populations with serious chronic illness such as ESKD/HD. We propose to conduct an adequately powered RCT (N=100) that ensures enrollment of approximately equal numbers of Hispanics, non-Hispanic Blacks, and non-Hispanic whites, with the following aims: 1) determine the short-term (at 2 weeks and upon conclusion of the 40-session 8-week tDCS protocol) and longer-term (12, 16 and 26 weeks after baseline) effects of at-home tDCS, versus sham stimulation, on pain (primary outcome) and on analgesic consumption, pain interference, depressed mood, and quality of life (secondary outcomes); 2) evaluate whether tDCS effects on outcomes vary by race/ethnicity; and 3) ascertain the tolerability of tDCS in terms of side effects and assess patient satisfaction with device use and study procedures. At-home tDCS is a highly promising nonpharmacologic treatment for pain in ESKD/HD. Establishing its longer-term effects could transform the way pain is managed in this ethnically diverse growing population of patients.