Pain Reduction Using Neurostimulation for End-Stage Kidney Disease
This study is testing if a small, battery-powered device called active tDCS (transcranial direct current stimulation) can help reduce chronic pain in people with end-stage kidney disease who are receiving hemodialysis. The device is worn on the head and delivers a very mild electrical stimulation that is barely noticeable. You would apply the device yourself at home, five times a week for eight weeks, with supervision from study staff. Some participants will receive the active tDCS, while others will receive a sham tDCS (a device that looks and feels the same but doesn't deliver active stimulation). The main goal is to see if the active tDCS can reduce your worst pain intensity over a 7-day period after 8 weeks. To join, you must be at least 21 years old, have end-stage kidney disease and be on hemodialysis, have chronic pain for at least 3 months with a pain intensity of 4 or higher, and be medically stable. The study's current status is unclear.
- Study design
- This is an interventional study planning to enroll 125 participants. It compares an active device (active tDCS) to a sham device (sham tDCS).
- What's involved
- You would self-apply the device 5 times per week for eight consecutive weeks at home, with in-person supervision from study personnel.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your pain intensity will be measured at the beginning of the study and again at the end of the 8-week intervention period.
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Pain Reduction Using NEurostimulation Study
At a glance
Conditions
Where it's being run
2 sites across 1 statesStudy leadership
- Cary Reid, MD, PhD · PRINCIPAL_INVESTIGATOR · Weill Medical College of Cornell University
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Change in worst pain intensity over past 7 daysBaseline, 8 weeks (at the end of intervention)
Pain intensity will be measured by one question from the PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Intensity - Short Form 3a. This 3-item instrument assesses how much a person hurts. This question asks in the past 7 days, "How intense was your pain at its worst?" Respondents report their pain on a 5-point scale: 1=Had no pain, 2=Mild, 3=Moderate, 4=Severe, and 5=Very severe.