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

提供家庭非药物干预（经颅神经刺激）以减轻接受血液透析的终末期肾病患者的疼痛

• 批准号: 10527378
• 负责人: Helena Knotkova
• 金额: $ 57.8万
• 依托单位: WEILL MEDICAL COLL OF CORNELL UNIV
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-12-01 至 2025-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10527378
• 关键词: Address; Adherence; Adult; Adverse effects; Affect; Age; Analgesics; Black American; Black Populations; Black race; Body mass index; Cephalic; Characteristics; Chronic; Chronic Disease; Client satisfaction; Clinical; Cognitive; Consumption; Depressed mood; Devices; Disease; End stage renal failure; Enrollment; Ensure; Ethnic Origin; Ethnic Population; Face; Fracture; Health; Healthcare Systems; Hemodialysis; Hispanic; Hispanic Populations; Home; Hospitalization; Interdisciplinary Study; Intervention; Knowledge; Long-Term Effects; Medicine; Minority; Minority Groups; Mission; Moods; Motor Cortex; Not Hispanic or Latino; Opioid; Outcome; Pain; Pain Management Method; Pain intensity; Pain interference; Pain management; Palliative Care; Participant; Patients; Persons; Pharmaceutical Preparations; Pharmacotherapy; Population; Practice Management; Prevalence; Procedures; Protocols documentation; Quality of life; Race; Randomized; Randomized, Controlled Trials; Reporting; Risk; Safety; Sample Size; Sampling; Supervision; Tablets; Telephone; Therapeutic Intervention; Time; Treatment outcome; United States National Institutes of Health; Universities; Work; adverse outcome; biological sex; chronic pain; chronic pain management; efficacy evaluation; ethnic diversity; ethnic minority; evidence base; experience; falls; follow-up; follower of religion Jewish; improved; innovation; metropolitan; minimal risk; mortality; neuroregulation; nondrug therapy; novel; opioid therapy; pain reduction; patient population; people of color; post intervention; primary outcome; racial minority; racial population; satisfaction; secondary outcome; side effect; sociodemographics; telehealth; transcranial direct current stimulation; treatment arm; treatment effect

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.

项目概要 超过 500,000 名终末期肾病 (ESKD) 患者接受慢性血液透析 (HD) 美国 ESKD/HD 的患病率每年都在增加，特别是在少数族裔中。 迫切需要解决 ESKD/HD 患者日常面临的许多临床问题。 高达 90% 的 ESKD/HD 患者面临的紧迫问题是疼痛管理不当，影响情绪； 药物治疗仍然是最常见的治疗方法。 控制疼痛和大量 ESKD/HD 患者继续接受长期阿片类药物治疗。 这种控制疼痛的方法受到不良后果的巨大风险的限制，包括跌倒、骨折、 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。 鉴于 ESKD/HD 在有色人种中的患病率不断增加，至关重要的是 研究严格评估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，被称为 风险最小，可以减少不同类型慢性病患者的疼痛和镇痛药用量 之前的随机对照试验（RCT）受到小样本量和刺激的限制。 方案简短（≤10 次），未采用家庭刺激功能，并且仅具有 评估短期效果，即大多采用 4 周或更短的干预后随访。 据我们所知，尚无 tDCS 镇痛试验评估长期治疗结果或确定 治疗效果是否随种族/民族状况而变化。 我们来自纽约州康奈尔大学威尔康奈尔医学院的经验丰富的多学科研究团队， 纽约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，该方法使 适合患有 ESKD/HD 等严重慢性疾病人群的长期刺激方案。 建议进行一项充分有力的 RCT（N=100），以确保入学人数大致相等 西班牙裔、非西班牙裔黑人和非西班牙裔白人的数量，目标如下： 1) 确定 短期（2 周时以及 40 次为期 8 周的 tDCS 方案结束后）和长期（12、16 以及基线后 26 周）家庭 tDCS 与假刺激对疼痛（主要结果）和 关于镇痛药用量、疼痛干扰、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 的耐受性； 副作用并评估患者对设备使用和研究程序的满意度。 对于 ESKD/HD 疼痛的非药物治疗非常有前景，确定其长期效果可能是可行的。 改变这个不断增长的种族多元化患者群体的疼痛管理方式。