Using a device to reduce pain in patients on dialysis
Delivery of an At-Home Nonpharmacologic Intervention (Transcranial Neurostimulation) to Mitigate Pain in Patients With End Stage Kidney Disease Receiving Hemodialysis
This study is testing a small device that uses mild electrical stimulation to see if it can help reduce pain for people on dialysis due to kidney disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 125 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Weill Medical College of Cornell University Academic / other |
| Locations | 2 sites (New York, New York and 1 other locations) |
| Trial ID | NCT05311956 on ClinicalTrials.gov |
What this trial studies
This project aims to evaluate the effectiveness of a small, battery-powered device that delivers mild electrical stimulation to reduce pain in patients undergoing hemodialysis due to end-stage kidney disease. Over four years, a randomized controlled trial will be conducted to assess the efficacy of this at-home transcranial direct current stimulation (tDCS) device. The study will focus on improving pain management and overall quality of life for patients, particularly among diverse racial and ethnic groups. The trial will include both active and sham stimulation to determine the true effects of the intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 and older with end-stage kidney disease who are currently receiving hemodialysis and experiencing chronic pain.
Not a fit: Patients with active medical or major psychiatric illnesses that could interfere with the study or those with a history of significant head trauma or other neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-drug alternative for pain management in patients receiving hemodialysis.
How similar studies have performed: While the use of tDCS for pain management is an emerging field, similar studies have shown promise in other populations, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
New York, New York and 1 other locations
- The Rogosin Institute — New York, New York, United States (Recruiting)
- NewYork-Presbyterian - Weill Cornell Medicine — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Cary Reid, MD, PhD — Weill Medical College of Cornell University
- Study coordinator: Cary Reid, MD, PhD
- Email: mcr2004@med.cornell.edu
- Phone: 212-746-1378
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.