RECRUITING

Pain Reduction Using NEurostimulation Study

Conditions

End Stage Kidney Disease Chronic Pain Dialysis transcranial direct current stimulation (tDCS)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-10-24

Study Completion:2027-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05311956

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.

Ages Eligible for Study:21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Cary Reid, MD, PhD

CONTACT

212-746-1378

mcr2004@med.cornell.edu

Patricia Kim, MSW

CONTACT

212-746-1758

pak2020@med.cornell.edu

Principal Investigator

Cary Reid, MD, PhD

PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Study Locations (Sites)

The Rogosin Institute

New York, New York, 10021

United States

NewYork-Presbyterian - Weill Cornell Medicine

New York, New York, 10065

United States

Collaborators and Investigators

Sponsor: Weill Medical College of Cornell University

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-24

Study Completion Date2027-12-31

Study Record Updates

Study Start Date2022-10-24

Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

Dialysis
transcranial direct current stimulation (tDCS)

Additional Relevant MeSH Terms

End Stage Kidney Disease
Chronic Pain