Pain Reduction Using NEurostimulation Study

Description

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.

Conditions

End Stage Kidney Disease, Chronic Pain

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Study Overview

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Study Details

Study overview

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.

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

Pain Reduction Using NEurostimulation Study

Condition
End Stage Kidney Disease
Intervention / Treatment

-

Contacts and Locations

New York

The Rogosin Institute, New York, New York, United States, 10021

New York

NewYork-Presbyterian - Weill Cornell Medicine, New York, New York, United States, 10065

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

21 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Weill Medical College of Cornell University,

Cary Reid, MD, PhD, PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University

Study Record Dates

2027-12-31