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

Trial Summary

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 data supports the effectiveness of this treatment for chronic pain in kidney failure?

Research shows that transcranial direct current stimulation (tDCS) can help reduce pain in various conditions, such as diabetic nerve pain and chronic pain in Alzheimer's patients. This suggests it might also be effective for managing chronic pain in kidney failure. ^{1 2 3 4 5}

Is transcranial direct current stimulation (tDCS) safe for humans?

Transcranial direct current stimulation (tDCS) has been studied for various conditions and is generally considered safe for humans, with studies showing it to be feasible and acceptable for pain management in different populations, including those with Alzheimer's and chronic pain. ^{1 2 3 4 5}

How does the treatment Active tDCS differ from other treatments for chronic pain in kidney failure?

Active tDCS is a non-invasive treatment that uses a mild electrical current to stimulate specific areas of the brain, offering a promising alternative to traditional pain medications like opioids, which can have significant risks. Unlike drugs, tDCS does not involve taking medication and can be administered at home, making it a convenient option for managing chronic pain. ^{1 3 4 5 6}

What is the purpose of this trial?

This is a 4-year project to see if a small battery-powered, device attached to a headband, that sits on the skin surface and delivers what is a hardly noticeable level of electrical stimulation can reduce pain in patients who receive hemodialysis on an ongoing basis.

Research Team

Cary Reid, MD, PhD

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

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

2. Netherlands pubmed.ncbi.nlm.nih.gov

Does anodal transcranial direct current stimulation modulate sensory perception and pain? A meta-analysis study. [2022]

3. Switzerland 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). [2023]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

Randomized, sham controlled trial of transcranial direct current stimulation for painful diabetic polyneuropathy. [2022]

5. Switzerland 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. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

tDCS modulates cortical nociceptive processing but has little to no impact on pain perception. [2022]