Neurostimulation for Chronic Pain in Kidney Failure
(PRUNE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a small device that delivers mild electrical stimulation to the head to determine if it can reduce pain in people with chronic kidney failure who regularly undergo hemodialysis. The study compares real treatment, known as Active tDCS (Transcranial Direct Current Stimulation), with a placebo, called Sham tDCS, to assess any true effect. It suits those who have experienced kidney disease and pain for over three months and are stable in their medical condition. Participants should speak English or Spanish and must feel comfortable with a device on their head. As an unphased trial, this study offers a unique opportunity to explore innovative pain relief methods for hemodialysis patients.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this neurostimulation device is safe for patients with kidney failure?
Research has shown that transcranial direct current stimulation (tDCS) is generally well-tolerated. In studies involving individuals with kidney disease undergoing dialysis, tDCS did not significantly alter blood pressure or heart rate, indicating its safety for this group. Other studies have used tDCS to alleviate pain from conditions such as fibromyalgia and migraines, finding it safe for use.
Although researchers continue to study tDCS, current evidence suggests it is a safe option for reducing pain without serious side effects.12345Why are researchers excited about this trial?
Researchers are excited about transcranial direct current stimulation (tDCS) for chronic pain in kidney failure because it offers a non-invasive approach that targets the brain's motor cortex to potentially reduce pain. Unlike standard pain treatments like analgesics or opioids, which often come with significant side effects and risk of dependency, tDCS uses mild electrical currents to modulate brain activity, aiming to provide relief without medication. This innovative delivery method is particularly appealing for patients with kidney failure, who may have limited options due to their condition.
What evidence suggests that this neurostimulation device is effective for reducing chronic pain in kidney failure?
Research has shown that transcranial direct current stimulation (tDCS) can help reduce pain in people with end-stage kidney disease. In this trial, participants will receive either active tDCS or sham tDCS. Studies have found that ten sessions of tDCS on the brain's movement control area can improve pain, mood, and quality of life for these patients. This treatment uses a gentle electrical current delivered through a device worn on the head. It likely works by altering brain activity related to pain, making it a promising option for those experiencing chronic pain during dialysis. Early results suggest it could effectively provide relief.36789
Who Is on the Research Team?
Cary Reid, MD, PhD
Principal Investigator
Weill Medical College of Cornell University
Are You a Good Fit for This Trial?
This trial is for English-speaking adults over 21 with chronic pain (intensity ≥4/10) for at least 3 months, who are undergoing hemodialysis for end-stage kidney disease. They must be cognitively able to consent and participate in the study without major psychiatric illnesses or medical conditions that could affect their pain or interfere with the trial.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either sham or active tDCS treatment over eight consecutive weeks, with 5 sessions per week
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of pain intensity, quality of life, and adverse events
What Are the Treatments Tested in This Trial?
Interventions
- Active tDCS
- Sham tDCS
Active tDCS is already approved in United Kingdom, Brazil for the following indications:
- Depression
- Depression
Find a Clinic Near You
Who Is Running the Clinical Trial?
Weill Medical College of Cornell University
Lead Sponsor
Cornell University
Collaborator
Metropolitan Jewish Health System
Collaborator
Rogosin Institute
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator