Delivery of an at-home transcranial direct current stimulation intervention to mitigate pain in patients with end-stage kidney disease receiving hemodialysis (ESKD/HD)

Frontiers in Pain Research

Pain Research

Charles R. Henderson¹  Melissa W. Frederic²  M. Carrington Reid²  Patricia Kim²  Jordan Van Zyl³  Helena Knotkova⁴  Russell K. Portenoy⁵  Nathaniel Berman⁶ 

[1] Department of Psychology, Cornell University, Ithaca, NY, United States;Division of Geriatrics and Palliative Medicine, Weill Cornell Medicine, New York, NY, United States;MJHS Institute for Innovation in Palliative Care, New York, NY, United States;MJHS Institute for Innovation in Palliative Care, New York, NY, United States;Department of Family & Social Medicine, Albert Einstein College of Medicine, Bronx, NY, United States;MJHS Institute for Innovation in Palliative Care, New York, NY, United States;Department of Family & Social Medicine, Albert Einstein College of Medicine, Bronx, NY, United States;Department of Neurology, Albert Einstein College of Medicine, Bronx, NY, United States;Rogosin Institute, Weill Cornell Medicine, New York, NY, United States;Division of Nephrology and Hypertension, Weill Cornell Medicine, New York, NY, United States;

关键词: transcranial direct current stimulation (tDCS);    non-invasive neurostimulation;    end-stage kidney disease (ESKD);    hemodialysis (HD);    chronic pain;    clinical trial protocol;   

DOI  :  10.3389/fpain.2023.1132625

 received in 2022-12-27, accepted in 2023-03-20,  发布年份 2023

来源: Frontiers

【 摘 要 】

BackgroundPoorly controlled pain remains a problem for many patients with end-stage kidney disease requiring hemodialysis (ESKD/HD) and customary approaches to pain management (e.g., opioids, non-steroidals) confer substantial risk. Accordingly, non-pharmacologic therapies are needed for use in this population. Non-invasive transcranial Direct Current Simulation (tDCS) constitutes a promising nonpharmacologic method for pain management in affected individuals.AimsThis study seeks to: 1) determine the effects of an 8-week course of at-home tDCS vs. sham tDCS on pain intensity, pain interference, medication usage, quality of life, and mood; 2) determine if tDCS effects vary by race/ethnicity; and 3) ascertain patient satisfaction with device use.MethodsThis double-blind, randomized, sham-controlled clinical trial will enroll 100 ESKD/HD patients with moderate-to-severe (≥4 on 0–10 scale) chronic pain. The active study intervention consists of 20 min of tDCS delivered over the primary motor cortex 5 days/week for 8 weeks. The comparator is a sham procedure that provides no effective stimulation. The primary outcome analysis will evaluate efficacy of tDCS for pain reduction after two months of stimulation. We will also assess the effects of treatment on analgesic consumption, pain interference, depressed mood, and quality of life. The statistical plan will include fixed classification factors for treatment (vs. sham), clinic sites, and assessment time, and the interaction of these factors adjusting for covariates (e.g., race/ethnicity, pain level).ConclusionAt-home tDCS constitutes a promising nonpharmacologic treatment for pain mitigation in persons with ESKD/HD. This unique RCT could transform the way pain is managed in this vulnerable population.Trial RegistrationNCT05311956.

【 授权许可】

Unknown   
© 2023 Van Zyl, Knotkova, Kim, Henderson Jr., Portenoy, Berman, Frederic and Reid.