Pain Reduction Using NEurostimulation Study (PRUNE)

Weill Cornell Medicine (WCM)

Status: Enrolling

Conditions: Chronic Pain; End Stage Kidney Disease

Treatments: Device: Sham tDCS; Device: Active tDCS

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05311956

R01DK131050 (U.S. NIH Grant/Contract)

21-07023793

22048 (Other Identifier)

Details and patient eligibility

About

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.

Full description

This is a 4-year R01 project to conduct a randomized controlled trial to evaluate the efficacy of an at-home transcranial direct current stimulation (tDCS) device to mitigate pain in persons receiving hemodialysis (HD) on account of end-stage kidney disease (ESKD). Pain is a highly common and morbid condition among persons with ESKD requiring HD. Because the current method of managing pain in this population typically involves the use of analgesic medications that confer substantial health risks, novel non-drug therapies are needed to reduce pain and lessen reliance on opioid and other drug therapies. The investigators will undertake a randomized controlled trial to determine the efficacy of an at-home neuromodulatory device to mitigate pain and improve other salient outcomes (e.g., mood, quality of life) in a stratified sample of Hispanic or Latino(a), Black or African American, and non-Hispanic White ESKD patients requiring HD. However, no individuals will be excluded based on race/ethnicity

Enrollment: 125 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients:

• Age ≥ 21 years
• Diagnosis of end stage kidney disease (OCD 18.6) and receiving hemodialysis
• Montreal Cognitive Assessment (MoCA-Blind) adjusted score of≥18;
• Pain for ≥3 months, with a self-reported pain intensity of ≥4 (on a 0-10 scale) during the week preceding the screening;
• Speaks English or Spanish
• Medically stable, as determined by clinician and defined as unlikely to undergo a substantial change in illness or treatment during the next 3 months
• Able to provide written informed consent.

Caregivers:

• Age ≥21 years
• Serves as primary caregiver for ESKD patient (e.g., partner, adult child, friend)
• Speaks English or Spanish

Exclusion criteria

• Active medical or major psychiatric illnesses that will impact pain or interfere with study procedures
• History of head trauma, seizure disorder, brain surgery, stroke, or cancer affecting head, metal implants in the head, or compromised skin integrity on the head in the area where electrodes will be placed
• Use of another neurostimulation device (such as spinal cord stimulator, cardio-stimulator implanted cardioverter-defibrillator)
• Not able to respond to brief questionnaires and rating scales that will interfere with study procedures
• Does not tolerate tDCS at a skin test (performed at training Visit 2)
• Does not provide informed consent

Exclusion criteria for all above groups:

* Does not speak English or Spanish

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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125 participants in 2 patient groups

Experimental

Experimental group

Description:

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).

Treatment:

Device: Active tDCS

Sham Comparator

Sham Comparator group

Description:

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:

Device: Sham tDCS