Status:
RECRUITING
Pain Reduction Using NEurostimulation Study
Lead Sponsor:
Weill Medical College of Cornell University
Collaborating Sponsors:
Metropolitan Jewish Health System
Rogosin Institute
Conditions:
End Stage Kidney Disease
Chronic Pain
Eligibility:
All Genders
21+ years
Phase:
NA
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 re...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT05311956
Start Date
October 24 2022
End Date
December 31 2027
Last Update
September 30 2025
Active Locations (2)
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1
The Rogosin Institute
New York, New York, United States, 10021
2
NewYork-Presbyterian - Weill Cornell Medicine
New York, New York, United States, 10065