Pain Reduction Using NEurostimulation Study

NCT ID: NCT05311956

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-24
• Study Completion Date: 2027-12-31

Brief 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.

Detailed Description

This is a 4-year R01 project to conduct a randomized controlled trial to evaluate the efficacy of an at-home transcranial direct current stimulation (tDCS) device to mitigate pain in persons receiving hemodialysis (HD) on account of end-stage kidney disease (ESKD). Pain is a highly common and morbid condition among persons with ESKD requiring HD. Because the current method of managing pain in this population typically involves the use of analgesic medications that confer substantial health risks, novel non-drug therapies are needed to reduce pain and lessen reliance on opioid and other drug therapies. The investigators will undertake a randomized controlled trial to determine the efficacy of an at-home neuromodulatory device to mitigate pain and improve other salient outcomes (e.g., mood, quality of life) in a stratified sample of Hispanic or Latino(a), Black or African American, and non-Hispanic White ESKD patients requiring HD. However, no individuals will be excluded based on race/ethnicity

Conditions

End Stage Kidney Disease; Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental

Patients will receive tDCS delivered over the motor cortex, at an intensity of 2mA, delivered for 20 minutes 5 times each week over eight consecutive weeks (40 applications in total).

Group Type: EXPERIMENTAL

Active tDCS

Intervention Type: DEVICE

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.

Sham Comparator

Sham treatment will consist of 30 seconds of the direct current at 2mA and 0 current for the remaining time of the 20-minute application 5 times per week over eight consecutive weeks (40 applications in total).

Group Type: SHAM_COMPARATOR

Sham tDCS

Intervention Type: DEVICE

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.

Interventions

Active 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.

Intervention Type: DEVICE

Sham 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.

Intervention Type: DEVICE

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

• Does not speak English or Spanish

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Metropolitan Jewish Health System

OTHER

Sponsor Role: collaborator

Rogosin Institute

UNKNOWN

Sponsor Role: collaborator

Cornell University

OTHER

Sponsor Role: collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cary Reid, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

The Rogosin Institute

New York, New York, United States

Site Status: RECRUITING

NewYork-Presbyterian - Weill Cornell Medicine

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Cary Reid, MD, PhD

Role: CONTACT

mcr2004@med.cornell.edu

212-746-1378

Patricia Kim, MSW

Role: CONTACT

pak2020@med.cornell.edu

212-746-1758

Facility Contacts

Nathaniel Berman, MD

Role: primary

nab2009@nyp.org

212-746-9766

Cary Reid, MD, PhD

Role: primary

mcr2004@med.cornell.edu

212-746-1378

Patricia Kim, MSW

Role: backup

pak2020@med.cornell.edu

212-746-1758

References

Van Zyl J, Knotkova H, Kim P, Henderson CR Jr, Portenoy RK, Berman N, Frederic MW, Reid MC. Delivery of an at-home transcranial direct current stimulation intervention to mitigate pain in patients with end-stage kidney disease receiving hemodialysis (ESKD/HD). Front Pain Res (Lausanne). 2023 Apr 5;4:1132625. doi: 10.3389/fpain.2023.1132625. eCollection 2023.

Reference Type: DERIVED

PMID: 37092011 (View on PubMed)

Other Identifiers

R01DK131050

Identifier Type: NIH

Identifier Source: secondary_id

View Link

22048

Identifier Type: OTHER

Identifier Source: secondary_id

21-07023793

Identifier Type: -

Identifier Source: org_study_id