Delivery of an At-Home Nonpharmacologic Intervention (Transcranial Neurostimulation) to Mitigate Pain in Patients With End Stage Kidney Disease Receiving Hemodialysis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 125
- Locations
- 2
- Primary Endpoint
- Change in worst pain intensity over past 7 days
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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.
- •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
Arms & Interventions
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).
Intervention: Active tDCS (Device)
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).
Intervention: Sham tDCS (Device)
Outcomes
Primary Outcomes
Change in worst pain intensity over past 7 days
Time Frame: Baseline, 8 weeks (at the end of intervention)
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.
Secondary Outcomes
- Number of related adverse events(Up to 26-weeks post-baseline)
- 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 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.)
- Satisfaction with the tDCS-TH device and procedure(8 weeks (at the end of intervention))
- Change in Quality of Life Questionnaire Score (WHOQOL-BREF)(Baseline, 2 weeks (during intervention), 8 weeks (at the end of intervention), 12, 16, and 26 weeks post-baseline.)
- Number of possibly related adverse events(Up to 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 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.)
- Number of probably related adverse events(Up to 26-weeks post-baseline)