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

Description

This is a 4-year project to see if a small battery-powered, device attached to a headband, that sits on the skin surface and delivers what is a hardly noticeable level of electrical stimulation can reduce pain in patients who receive hemodialysis on an ongoing basis.This is a 4-year R01 project to conduct a randomized controlled trial to evaluate the efficacy of an at-home transcranial direct current stimulation (tDCS) device to mitigate pain in persons receiving hemodialysis (HD) on account of end-stage kidney disease (ESKD). Pain is a highly common and morbid condition among persons with ESKD requiring HD. Because the current method of managing pain in this population typically involves the use of analgesic medications that confer substantial health risks, novel non-drug therapies are needed to reduce pain and lessen reliance on opioid and other drug therapies. The investigators will undertake a randomized controlled trial to determine the efficacy of an at-home neuromodulatory devic

Trial Eligibility

Inclusion Criteria: Patients: * Age ≥ 21 years * Diagnosis of end stage kidney disease (OCD 18.6) and receiving hemodialysis * Montreal Cognitive Assessment (MoCA-Blind) adjusted score of≥18; * Pain for ≥3 months, with a self-reported pain intensity of ≥4 (on a 0-10 scale) during the week preceding the screening; * Speaks English or Spanish * Medically stable, as determined by clinician and defined as unlikely to undergo a substantial change in illness or treatment during the next 3 months * Able to provide written informed consent. Caregivers: * Age ≥21 years * Serves as primary caregiver for ESKD patient (e.g., partner, adult child, friend) * Speaks English or Spanish Exclusion Criteria: * Active medical or major psychiatric illnesses that will impact pain or interfere with study procedures * History of head trauma, seizure disorder, brain surgery, stroke, or cancer affecting head, metal implants in the head, or compromised skin integrity on the head in the area where electrodes will be placed * Use of another neurostimulation device (such as spinal cord stimulator, cardio-stimulator implanted cardioverter-defibrillator) * Not able to respond to brief questionnaires and rating scales that will interfere with study procedures * Does not tolerate tDCS at a skin test (performed at training Visit 2) * Does not provide informed consent Exclusion criteria for all above groups: \* Does not speak English or Spanish

Study Info

Interventions

Locations Recruiting

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