RecruitingNot ApplicableNCT05311956

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

Sponsor

Weill Medical College of Cornell University

Enrollment

125 participants

Start Date

Oct 24, 2022

Study Type

INTERVENTIONAL

Conditions

Chronic Pain End-stage Kidney Disease

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.

Eligibility

Min Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether neurostimulation (a non-drug treatment that uses gentle electrical signals to calm overactive nerves) can reduce chronic pain in people with end-stage kidney disease who are on dialysis. Dialysis patients often experience significant pain that is hard to manage. **You may be eligible if...** - You are 21 or older with end-stage kidney disease receiving hemodialysis (dialysis through a blood filter) - You have had ongoing pain for 3 or more months, with a pain rating of at least 4 out of 10 - You have adequate cognitive function (score of 18+ on a standard test) - You speak English or Spanish - You are medically stable and unlikely to have major changes in treatment over the next 3 months - Caregivers of qualifying patients may also participate **You may NOT be eligible if...** - You have active serious medical or psychiatric conditions that would interfere with the study - You have a pacemaker or other implanted electrical device that could be affected by neurostimulation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEActive 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.

DEVICESham 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.