Pain Reduction Using NEurostimulation Study

Launched by WEILL MEDICAL COLLEGE OF CORNELL UNIVERSITY · Mar 28, 2022

Keywords

ClinConnect Summary

The Pain Reduction Using NEurostimulation Study is a research project that aims to find out if a small, battery-powered device can help reduce pain for people with end-stage kidney disease who are receiving hemodialysis. This device is worn on the head like a headband and delivers a gentle, barely noticeable electrical stimulation to the skin. The study will take place over four years and is currently looking for participants aged 21 and older who have been experiencing ongoing pain for at least three months.

To be eligible for the study, participants must have a diagnosis of end-stage kidney disease and be currently receiving hemodialysis. They should also be medically stable and able to communicate in English or Spanish. Participants will need to provide informed consent, meaning they understand the study and agree to take part. Throughout the study, participants can expect to wear the device and answer some questionnaires about their pain and overall well-being. This trial may offer a new way to manage pain for individuals facing the challenges of kidney disease.

Gender

ALL

Eligibility 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