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

项目总结 超过50,000名终末期肾病(ESKD)患者接受慢性血液透析(HD) 每年都在美国。ESKD/HD的流行率正在增加，特别是在种族/族裔少数群体中。的确有 迫切需要解决ESKD/HD患者经常面临的许多临床问题。其中最 迫在眉睫的担忧是管理不善的痛苦。高达90%的ESKD/HD患者会受到疼痛的影响； 功能和总体生活质量(QOL)。药物治疗仍然是最常见的治疗方法 治疗疼痛和相当数量的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巨大风险的限制，包括摔倒、骨折、 和住院治疗。需要新的非药物疗法来减轻疼痛和减少对阿片类药物治疗的依赖 在病人群体中。鉴于ESKD/HD在有色人种中的患病率越来越高，至关重要的是 研究严格评估了新疗法在少数民族人群中的安全性和有效性。 经颅直流电刺激(Tdcs)是一种非侵入性的神经调节疗法，被称为 风险最小，可减少不同类型慢性前列腺癌患者的疼痛和止痛药消耗 疼痛。以往的随机对照试验(RCT)一直受到样本量小和刺激的限制 简短的协议(≤10会话)，没有使用家庭刺激功能，并且只有 评估短期效果，即主要采用4周或以下的干预后随访。发送到 据我们所知，还没有tdcs止痛药试验评估或确定长期治疗结果。 治疗效果是否随着种族/民族状况的不同而不同。 我们经验丰富的多学科研究团队来自威尔康奈尔医学/康奈尔大学，纽约， 纽约罗戈辛研究所和纽约大都会犹太人医疗保健系统(MJHS)创新研究所 纽约州的姑息治疗开创了一种在家远程监控的远程医疗方法，使 长期刺激方案适用于患有严重慢性病的人群，如ESKD/HD。我们 建议实施一项动力充足的随机对照试验(N=100)，以确保招生人数大致相等 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(2周和40届会议8周tdcs方案结束后)和长期(12、16 和基线后26周)家庭TDC与假刺激相比，对疼痛(主要结果)和 关于止痛药消费、疼痛干预、抑郁情绪和生活质量(次要结果)； 评估tdcs对结果的影响是否因种族/民族而异；以及3)确定tdcs在 评估患者对设备使用和研究程序的满意度。在家tdcs是一种 ESKD/HD疼痛的非药物治疗前景看好。确定其较长期的影响可能 在这个种族多元化的不断增长的患者群体中，改变疼痛的管理方式。

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.