Clinical trial NCT05311956: Pain Reduction Using NEurostimulation Study
Official title: Delivery of an At-Home Nonpharmacologic Intervention (Transcranial Neurostimulation) to Mitigate Pain in Patients With End Stage Kidney Disease Receiving Hemodialysis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: End Stage Kidney Disease
Chronic Pain
Keywords: Dialysis
transcranial direct current stimulation (tDCS)
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Metropolitan Jewish Health System
name: Rogosin Institute
name: Cornell University
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2022-04-05
Enrollment: 125
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Exclusion criteria for all above groups:

\* Does not speak English or Spanish

Primary outcomes:
measure: Change in worst pain intensity over past 7 days
timeFrame: Baseline, 8 weeks (at the end of intervention)
Secondary outcomes:
measure: Change in worst pain intensity over past 7 days
timeFrame: Baseline, 2 weeks (during intervention), 8 weeks (at the end of intervention), 12, 16, and 26 weeks post-baseline.
measure: Change in average pain intensity over past 7 days (PROMIS pain intensity short form)
timeFrame: Baseline, 2 weeks (during intervention), 8 weeks (at the end of intervention), 12, 16, and 26 weeks post-baseline.
measure: Change in self-report pain and pain-related medication use
timeFrame: Baseline, 2 weeks (during intervention), 8 weeks (at the end of intervention), 12, 16, and 26 weeks post-baseline.
measure: Change in Pain interference (PROMIS pain interference short form)
timeFrame: Baseline, 2 weeks (during intervention), 8 weeks (at the end of intervention), 12, 16, and 26 weeks post-baseline.
measure: Change in Depressive Symptoms (Patient Health Questionnaire; PHQ-8)
timeFrame: Baseline, 2 weeks (during intervention), 8 weeks (at the end of intervention), 12, 16, and 26 weeks post-baseline.
measure: Change in Quality of Life Questionnaire Score (WHOQOL-BREF)
timeFrame: Baseline, 2 weeks (during intervention), 8 weeks (at the end of intervention), 12, 16, and 26 weeks post-baseline.
measure: Satisfaction with the tDCS-TH device and procedure
timeFrame: 8 weeks (at the end of intervention)
measure: Number of related adverse events
timeFrame: Up to 26-weeks post-baseline
measure: Number of probably related adverse events
timeFrame: Up to 26-weeks post-baseline
measure: Number of possibly related adverse events
timeFrame: Up to 26-weeks post-baseline
Other outcomes:
Locations:
city: New York
country: United States
facility: The Rogosin Institute
state: New York
city: New York
country: United States
facility: NewYork-Presbyterian - Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Cary Reid, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: