Neurostimulation for Chronic Pain in Kidney Failure

(PRUNE Trial)

Recruiting at 1 trial location

Overseen By Patricia Kim, MSW

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Major psychiatric illnesses, Head trauma, Seizure disorder, Neurostimulation device, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 40

Duration: 8 weeks

125 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{3 6 7 8 9}

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

My health condition is stable and not expected to change significantly in the next 3 months.

I am 21 years old or older.

Patients: Speaks English

Exclusion 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.

Patients: Does not provide informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either sham or active tDCS treatment over eight consecutive weeks, with 5 sessions per week

8 weeks

40 sessions (at-home)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of pain intensity, quality of life, and adverse events

26 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Active tDCS
• Sham tDCS

Trial Overview

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.

How Is the Trial Designed?

Group I: Experimental Experimental Treatment 1 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 Comparator Placebo Group 1 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).

Active tDCS is already approved in United Kingdom, Brazil for the following indications:

Approved in United Kingdom as Transcranial Direct Current Stimulation for:

• Depression

Approved in Brazil as Transcranial Direct Current Stimulation for:

• Depression

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Cornell University

Collaborator

Trials

179

Recruited

14,090,000+

Metropolitan Jewish Health System

Collaborator

Trials

3

Recruited

680+

Rogosin Institute

Collaborator

Trials

2

Recruited

770+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

In a pilot study involving 40 older adults with Alzheimer's disease and related dementias, active transcranial direct current stimulation (tDCS) significantly reduced pain intensity compared to a sham treatment, indicating its potential efficacy for chronic pain relief.

The study demonstrated that home-based tDCS is a feasible and acceptable method for managing pain in this population, suggesting that further large-scale studies are warranted to explore its long-term benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, Acceptability, and Efficacy of Home-Based Transcranial Direct Current Stimulation on Pain in Older Adults with Alzheimer's Disease and Related Dementias: A Randomized Sham-Controlled Pilot Clinical Trial. Martorella, G., Miao, H., Wang, D., et al.[2023]

Anodal transcranial direct current stimulation (a-tDCS) applied to the primary motor cortex significantly increases sensory and pain thresholds in healthy individuals, with effect sizes of 22.19% and 19.28%, respectively.

In patients with chronic pain, a-tDCS applied to the primary motor cortex and dorsolateral prefrontal cortex resulted in a significant reduction in pain levels, with an average decrease in pain scores of 14.9% and 19.3%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does anodal transcranial direct current stimulation modulate sensory perception and pain? A meta-analysis study. Vaseghi, B., Zoghi, M., Jaberzadeh, S.[2022]

This study will evaluate the effectiveness of an 8-week at-home transcranial Direct Current Stimulation (tDCS) treatment for chronic pain in 100 patients with end-stage kidney disease undergoing hemodialysis, aiming to reduce pain intensity and improve quality of life.

tDCS is a promising non-pharmacologic alternative for pain management in this population, potentially reducing reliance on risky medications like opioids and non-steroidal anti-inflammatory drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivery of an at-home transcranial direct current stimulation intervention to mitigate pain in patients with end-stage kidney disease receiving hemodialysis (ESKD/HD). Van Zyl, J., Knotkova, H., Kim, P., et al.[2023]

In a study involving 80 healthy participants, high-definition transcranial direct current stimulation (HD-tDCS) did not significantly reduce pain intensity from nerve growth factor-induced pain, indicating limited efficacy in acute pain relief.

However, HD-tDCS was effective in reducing the facilitation of temporal summation of pain in participants experiencing induced pain, suggesting that its benefits may be more pronounced in individuals with sensitized central pain mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modulation of central pain mechanisms using high-definition transcranial direct current stimulation: A double-blind, sham-controlled study. Kold, S., Graven-Nielsen, T.[2023]

Transcranial direct current stimulation (tDCS) applied over the primary motor cortex (M1) significantly reduced pain in patients with painful diabetic polyneuropathy (PDPN), showing immediate effects and sustained relief for up to 4 weeks after treatment.

In a study of 60 patients, those receiving tDCS over M1 experienced greater pain reduction compared to those receiving sham or dorsolateral prefrontal cortex (DLPFC) stimulation, indicating that targeting M1 may be an effective approach for managing pain in PDPN.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized, sham controlled trial of transcranial direct current stimulation for painful diabetic polyneuropathy. Kim, YJ., Ku, J., Kim, HJ., et al.[2022]

In a study involving 16 healthy volunteers, transcranial direct current stimulation (tDCS) did not significantly alter brain activation in response to pain compared to sham stimulation, indicating limited immediate effects on cortical pain processing.

Anodal tDCS showed a slight reduction in pain ratings and heat sensitivity, but the overall impact was minimal, suggesting that further research with larger sample sizes and different stimulation parameters is needed to explore its therapeutic potential.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

tDCS modulates cortical nociceptive processing but has little to no impact on pain perception. Ihle, K., Rodriguez-Raecke, R., Luedtke, K., et al.[2022]

Citations

1.

sciencedirect.com

sciencedirect.com/science/article/pii/S0885392422007436

Transcranial Direct Current Stimulation (tDCS): Pain ...

Ten non-consecutive sessions of anodal M1 tDCS improved pain, quality of life, and mood in patients with end-stage renal disease.

2.

jpsmjournal.com

jpsmjournal.com/article/S0885-3924(22)00743-6/fulltext

Transcranial Direct Current Stimulation (tDCS): Pain ...

Ten non-consecutive sessions of anodal M1 tDCS improved pain, quality of life, and mood in patients with end-stage renal disease.

3.

nature.com

nature.com/articles/s41598-025-96415-7.pdf

Transcranial direct current stimulation over motor cortex ...

Patients affected by CKD evolve with poor quality of life, low physical function and chronic pain, specifically among patients with end-stage renal disease ( ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10113462/

Delivery of an at-home transcranial direct current stimulation ...

Association between NSAID use and mortality risk in patients with end-stage renal disease: a population-based cohort study. Clin Epidemiol. (2019) 11:429–41 ...

5.

trialsjournal.biomedcentral.com

trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3769-6

a study protocol for a double-blind controlled randomized trial

According to Brkovic et al. [3], end stage renal disease (ESRD) is defined as loss of renal function requiring renal replacement therapy (RRT) ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11268524/

Safety and feasibility of transcranial direct current stimulation ...

To assess the safety and feasibility of tDCS on blood pressure and heart rate in patients with end-stage renal disease undergoing hemodialysis.

7.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0885392422007436

Transcranial Direct Current Stimulation (tDCS): Pain ...

This preliminary study shows improvement in pain, QoL, depression and anxiety with 10 non-consecutive days of anodal M1-SO tDCS.

8.

epain.org

epain.org/journal/view.html?uid=1917&vmd=Full

Effects of Transcranial Direct Current Stimulation on pain ...

Conclusions: Our findings suggest that tDCS might be effective for fibromyalgia, migraine, and neuropathic pain associated with spinal cord ...

9.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05863494

Transcranial Direct Current Stimulation and Chronic Pain

This clinical trial uses transcranial direct current stimulation (tDCS) using the patented tKIWI system to safely reduce self-reported chronic pain with ...