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Neurostimulation for Chronic Pain in Kidney Failure (PRUNE Trial)
PRUNE Trial Summary
This trial will test if a battery-powered device that sends electrical stimulation to the head can reduce pain for people who receive hemodialysis.
PRUNE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPRUNE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2012 Phase 3 trial • 60 Patients • NCT01649232PRUNE Trial Design
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Who is running the clinical trial?
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- I do not have any major illnesses or psychiatric conditions that could affect my pain levels or participation.I cannot complete short questionnaires or rating scales.My health condition is stable and not expected to change significantly in the next 3 months.I am 21 years old or older.I have had pain for over 3 months with a pain level of at least 4 out of 10.I have a history of head issues or surgeries that might affect where electrodes are placed.I have had pain for over 3 months with a pain level of at least 4 out of 10.You did not react well to a skin test for tDCS during the training visit.I am a caregiver and I am 21 years old or older.I, as a caregiver, can communicate in English.You scored 18 or higher on the Montreal Cognitive Assessment (MoCA-Blind).You are using another type of neurostimulation device, like a spinal cord stimulator or implanted cardioverter-defibrillator.I have end-stage kidney disease and am getting dialysis at a Rogosin site.You are the main person taking care of someone with end-stage kidney disease (e.g., spouse, grown-up child, friend).
- Group 1: Sham Comparator
- Group 2: Experimental
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there still openings available for participants in this trial?
"Affirmative. According to clinicaltrials.gov, this research trial has been actively searching for participants since October 24th 2022 and was recently updated on November 1st. The medical experiment is seeking 125 patients from 2 different locations."
How many volunteers are being recruited to the trial?
"Affirmative. According to the information available on clinicaltrials.gov, recruitment for this medical study is currently underway. The trial was initiated on October 24th 2022 and recently revised November 1st of the same year; 125 patients are needed at two research sites."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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