NCT05311956

Pain Reduction Using NEurostimulation Study

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 125 (estimated)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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 device to mitigate pain and improve other salient outcomes (e.g., mood, quality of life) in a stratified sample of Hispanic or Latino(a), Black or African American, and non-Hispanic White ESKD patients requiring HD. However, no individuals will be excluded based on race/ethnicity

Conditions

• End Stage Kidney Disease
• Chronic Pain

Interventions

Type	Name	Description
DEVICE	Active tDCS	The study intervention will be participants self-applying 40 tDCS active stimulations with in-person supervision provided by trained study personnel. The self-applied intervention will continue 5 times per week over eight consecutive weeks. Treatment will occur in the home.
DEVICE	Sham tDCS	In this arm of the study participants will self-apply 40 sham tDCS stimulations with in-person supervision provided by trained study personnel. The self-applied intervention will continue 5 times per week over eight consecutive weeks. Treatment will occur in the home.

Timeline

• Start date: 2022-10-24
• Primary completion: 2026-09-01
• Completion: 2027-12-31
• First posted: 2022-04-05
• Last updated: 2025-09-30

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study