RecruitingNot ApplicableNCT05311956

Pain Reduction Using NEurostimulation Study

Delivery of an At-Home Nonpharmacologic Intervention (Transcranial Neurostimulation) to Mitigate Pain in Patients With End Stage Kidney Disease Receiving Hemodialysis

Sponsor

Weill Medical College of Cornell University

Enrollment

125 participants

Start Date

Oct 24, 2022

Study Type

INTERVENTIONAL

Conditions

Chronic Pain End-stage Kidney Disease

Summary

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.

Eligibility

Min Age: 21 Years

Inclusion Criteria12

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 Criteria7

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
\* Does not speak English or Spanish

Interventions

DEVICEActive tDCS

The study intervention will be participants self-applying 40 tDCS active stimulations with in-person supervision provided by trained study personnel. The self-applied intervention will continue 5 times per week over eight consecutive weeks. Treatment will occur in the home.

DEVICESham tDCS

In this arm of the study participants will self-apply 40 sham tDCS stimulations with in-person supervision provided by trained study personnel. The self-applied intervention will continue 5 times per week over eight consecutive weeks. Treatment will occur in the home.