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Neurostimulation
Neurostimulation for Chronic Pain in Kidney Failure (PRUNE Trial)
N/A
Recruiting
Led By Cary Reid, MD, PhD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients: Medically stable, as determined by clinician and defined as unlikely to undergo a substantial change in illness or treatment during the next 3 months
Patients: Age ≥ 21 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 2 weeks (during intervention), 8 weeks (at the end of intervention), 12, 16, and 26 weeks post-baseline.
Awards & highlights
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.
Who is the study for?
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.Check my eligibility
What is being tested?
The study tests a headband device delivering low-level electrical stimulation (active tDCS) against a sham device to see if it can reduce chronic pain in patients receiving hemodialysis. It's a comparison between an active treatment and a placebo-like control.See study design
What are the potential side effects?
Potential side effects may include discomfort at the site of electrode placement, mild skin irritation on the head, headache, fatigue, or tingling sensations during use of the tDCS device.
PRUNE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My health condition is stable and not expected to change significantly in the next 3 months.
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I am 21 years old or older.
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I have had pain for over 3 months with a pain level of at least 4 out of 10.
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I have had pain for over 3 months with a pain level of at least 4 out of 10.
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I am a caregiver and I am 21 years old or older.
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I, as a caregiver, can communicate in English.
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I have end-stage kidney disease and am getting dialysis at a Rogosin site.
PRUNE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 2 weeks (during intervention), 8 weeks (at the end of intervention), 12, 16, and 26 weeks post-baseline.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 2 weeks (during intervention), 8 weeks (at the end of intervention), 12, 16, and 26 weeks post-baseline.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Change in Depressive Symptoms (Patient Health Questionnaire; PHQ-8)
Change in Pain interference (PROMIS pain interference short form)
Change in Quality of Life Questionnaire Score (WHOQOL-BREF)
+7 moreSide effects data
From 2012 Phase 3 trial • 60 Patients • NCT0164923210%
headache
10%
headedness / dizziness
7%
fatigue or nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Active tDCS
Controls
PRUNE Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ExperimentalExperimental Treatment1 Intervention
Patients will receive tDCS delivered over the motor cortex, at an intensity of 2mA, delivered for 20 minutes 5 times each week over eight consecutive weeks (40 applications in total).
Group II: Sham ComparatorPlacebo Group1 Intervention
Sham treatment will consist of 30 seconds of the direct current at 2mA and 0 current for the remaining time of the 20-minute application 5 times per week over eight consecutive weeks (40 applications in total).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Active tDCS
2012
Completed Phase 3
~1150
Find a Location
Who is running the clinical trial?
Cornell UniversityOTHER
166 Previous Clinical Trials
14,089,735 Total Patients Enrolled
Metropolitan Jewish Health SystemOTHER
2 Previous Clinical Trials
553 Total Patients Enrolled
Rogosin InstituteUNKNOWN
1 Previous Clinical Trials
643 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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).
Research Study Groups:
This trial has the following groups:- Group 1: Sham Comparator
- Group 2: Experimental
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
Who else is applying?
What site did they apply to?
NewYork-Presbyterian - Weill Cornell Medicine
What portion of applicants met pre-screening criteria?
Met criteria
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