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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: Age ≥ 21 years

Pain for ≥3 months, with a self-reported pain intensity of ≥4 (on a 0-10 scale) during the week preceding the screening;

Must not have

Patients: Active medical or major psychiatric illnesses that will impact pain or interfere with study procedures

Patients: Not able to respond to brief questionnaires and rating scales that will interfere with study procedures

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.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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 have end-stage kidney disease and am getting dialysis at a Rogosin site.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any major illnesses or psychiatric conditions that could affect my pain levels or participation.

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I cannot complete short questionnaires or rating scales.

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I have a history of head issues or surgeries that might affect where electrodes are placed.

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 2 weeks (during intervention), 8 weeks (at the end of intervention), 12, 16, and 26 weeks post-baseline. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

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 more

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 1

~1190

0 / 7Eligibility criteria met