Pain Reduction Using NEurostimulation Study

NCT05311956 | Recruiting DMC FDA Device

• 3 other identifiers: 21-07023793R01DK13105022048
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 2

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.

Conditions

End Stage Kidney Disease; Chronic Pain

Keywords

Dialysis; transcranial direct current stimulation (tDCS)

Outcome Measures

Primary Outcomes (1)

• Change in worst pain intensity over past 7 days

  Pain intensity will be measured by one question from the PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Intensity - Short Form 3a. This 3-item instrument assesses how much a person hurts. This question asks in the past 7 days, "How intense was your pain at its worst?" Respondents report their pain on a 5-point scale: 1=Had no pain, 2=Mild, 3=Moderate, 4=Severe, and 5=Very severe.

  Baseline, 8 weeks (at the end of intervention)

Secondary Outcomes (10)

• Change in worst pain intensity over past 7 days

  Baseline, 2 weeks (during intervention), 8 weeks (at the end of intervention), 12, 16, and 26 weeks post-baseline.

• Change in average pain intensity over past 7 days (PROMIS pain intensity short form)

  Baseline, 2 weeks (during intervention), 8 weeks (at the end of intervention), 12, 16, and 26 weeks post-baseline.

• Change in self-report pain and pain-related medication use

  Baseline, 2 weeks (during intervention), 8 weeks (at the end of intervention), 12, 16, and 26 weeks post-baseline.

• Change in Pain interference (PROMIS pain interference short form)

  Baseline, 2 weeks (during intervention), 8 weeks (at the end of intervention), 12, 16, and 26 weeks post-baseline.

• Change in Depressive Symptoms (Patient Health Questionnaire; PHQ-8)

  Baseline, 2 weeks (during intervention), 8 weeks (at the end of intervention), 12, 16, and 26 weeks post-baseline.

Study Arms (2)

Experimental

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).

Device: Active tDCS

Sham Comparator

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).

Device: Sham tDCS

Interventions

Active tDCS 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.

Experimental

Sham tDCS 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.

Sham Comparator

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Metropolitan Jewish Health System: collaborator
• Rogosin Institute: collaborator
• Cornell University: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

The Rogosin Institute

New York, New York, 10021, United States

RECRUITING

NewYork-Presbyterian - Weill Cornell Medicine

New York, New York, 10065, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 37092011 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic; Chronic Pain

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Cary Reid, MD, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cary Reid, MD, PhD

CONTACT

212-746-1378; mcr2004@med.cornell.edu

Patricia Kim, MSW

CONTACT

212-746-1758; pak2020@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: April 5, 2022
• Study Start: October 24, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)