Delivery of an At-Home Nonpharmacologic Intervention (Transcranial Neurostimulation) to Mitigate Pain in Patients With End Stage Kidney Disease Receiving Hemodialysis
Weill Medical College of Cornell University
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.
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 th…
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DeviceActive 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.
- DeviceSham 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.
Locations (2)
- The Rogosin InstituteNew York, New York
- NewYork-Presbyterian - Weill Cornell MedicineNew York, New York