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