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Pain Reduction Using NEurostimulation Study

Active, not recruitingNot applicableNCT05311956
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Delivery of an At-Home Nonpharmacologic Intervention (Transcranial Neurostimulation) to Mitigate Pain in Patients With End Stage Kidney Disease Receiving Hemodialysis
Conditions
Sponsor
Weill Medical College of Cornell University
Collaborators
Metropolitan Jewish Health System; Rogosin Institute; Cornell University; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date
2022-10-24
Primary completion
2026-01-28
Sex
All
Age range
from 21 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
2

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05311956