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Principal Investigator: Lara K Dhingra
Organization: WEILL MEDICAL COLL OF CORNELL UNIV
Fiscal Year: 2024
Award: $546,217
Funding agency: National Institute of Diabetes and Digestive and Kidney Diseases
PROJECT SUMMARY
More than 500,000 patients with end-stage kidney disease (ESKD) receive chronic hemodialysis (HD) in the
U.S. each year. The prevalence of ESKD/HD is increasing, particularly among racial/ethnic minorities. There is
a compelling need to address the many clinical concerns that ESKD/HD patients routinely face. One of the most
pressing concerns is poorly managed pain. Pain affects up to 90% of ESKD/HD patients; compromising mood,
functioning, and overall quality of life (QoL). Pharmacotherapy remains the most common approach to
managing pain and substantial numbers of ESKD/HD patients continue to receive long-term opioid treatment.
This approach to managing pain is limited by substantial risks of adverse outcomes, including falls, fractures,
and hospitalization. Novel non-drug therapies are needed to reduce pain and lessen reliance on opioid therapy
in the patient population. Given the increasing prevalence of ESKD/HD in persons of color, it is essential that
studies evaluate rigorously the safety and efficacy of new treatments in minority populations.
Transcranial direct current stimulation (tDCS) is a non-invasive neuromodulatory therapy, designated as
having minimal risk that can reduce pain and analgesic consumption in patients with diverse types of chronic
pain. Previous randomized controlled trials (RCTs) have been limited by small sample sizes and stimulation
protocols that are brief (≤10 sessions), have not employed at-home stimulation capability, and have only
assessed for short-term effects, i.e., mostly employed post-intervention follow-ups of 4 weeks or less. To the
best of our knowledge, no tDCS analgesic trial has evaluated longer-term treatment outcomes or determined
whether treatment effects vary as a function of race/ethnicity status.
Our highly experienced multidisciplinary research team from Weill Cornell Medicine/Cornell University, NY,
the Rogosin Institute, NY, and the Metropolitan Jewish Healthcare System (MJHS) Institute for Innovation in
Palliative Care, NY has pioneered an at-home, remotely supervised tDCS-telehealth approach that enables
long-term stimulation protocols suitable for populations with serious chronic illness such as ESKD/HD. We
propose to conduct an adequately powered RCT (N=100) that ensures enrollment of approximately equal
numbers of Hispanics, non-Hispanic Blacks, and non-Hispanic whites, with the following aims: 1) determine the
short-term (at 2 weeks and upon conclusion of the 40-session 8-week tDCS protocol) and longer-term (12, 16
and 26 weeks after baseline) effects of at-home tDCS, versus sham stimulation, on pain (primary outcome) and
on analgesic consumption, pain interference, depressed mood, and quality of life (secondary outcomes); 2)
evaluate whether tDCS effects on outcomes vary by race/ethnicity; and 3) ascertain the tolerability of tDCS in
terms of side effects and assess patient satisfaction with device use and study procedures. At-home tDCS is a
highly promising nonpharmacologic treatment for pain in ESKD/HD. Establishing its longer-term effects could
transform the way pain is managed in this ethnically diverse growing population of patients.
Terms: <21+ years old><Active Follow-up><Address><Adherence><Adult><Adult Human><Adverse effects><Affect><Age><Analgesic Agents><Analgesic Drugs><Analgesic Preparation><Analgesics><Anodynes><Antinociceptive Agents><Antinociceptive Drugs><BMI><BMI percentile><BMI z-score><Black><Black American><Black Populations><Black group><Black individual><Black people><Black race><Blacks><Body mass index><Cephalic><Characteristics><Chronic><Chronic Disease><Chronic Illness><Client satisfaction><Clinical><Cognitive><Consumption><Cranial><Depressed mood><Devices><Disease><Disorder><Drug Therapy><Drugs><ESRD><End stage renal failure><End-Stage Kidney Disease><End-Stage Renal Disease><Enrollment><Ensure><Ethnic Group><Ethnic Origin><Ethnic People><Ethnic Population><Ethnic individual><Ethnicity><Ethnicity People><Ethnicity Population><Face><Fracture><Health><Health Care Systems><Healthcare Systems><Hemodialyses><Hemodialysis><Hispanic><Hispanic Populations><Hispanic group><Hispanic individual><Hispanic people><Hispanics><Home><Hospital Admission><Hospitalization><Individuals from minority><Individuals of minority><Interdisciplinary Research><Interdisciplinary Study><Jewish><Judaism><Knowledge><Long-Term Effects><Longterm Effects><Medication><Medicine><Minority><Minority Groups><Minority People><Minority Population><Minority Status><Minority individual><Mission><Moods><Motor Cortex><Multidisciplinary Collaboration><Multidisciplinary Research><NIH><National Institutes of Health><Non-Hispanic><Non-pharmacologic Therapy><Nonhispanic><Nonpharmacologic Intervention><Nonpharmacologic Therapy><Nonpharmacologic approach><Nonpharmacologic treatment><Not Hispanic or Latino><Opiates><Opioid><Outcome><Pain><Pain Control><Pain Management Method><Pain Therapy><Pain intensity><Pain interference><Pain management><Painful><Palliative Care><Palliative Therapy><Palliative Treatment><Participant><Patient Satisfaction><Patients><Persons><Pharmaceutical Preparations><Pharmacotherapy><Phone><Population><Practice Management><Prevalence><Procedures><Protocol><Protocols documentation><QOL><Quality of life><Quetelet index><Race><Races><Racial Group><Randomized><Randomized, Controlled Trials><Reporting><Risk><Safety><Sample Size><Sampling><Supervision><Tablets><Telephone><Therapeutic Intervention><Time><Treatment outcome><United States National Institutes of Health><Universities><Work><active followup><adulthood><adverse consequence><adverse outcome><ages><biological sex><bone fracture><chronic disorder><chronic pain><chronic pain control><chronic pain intervention><chronic pain management><chronic pain therapy><chronic pain treatment><comfort care><depressed><determine efficacy><drug treatment><drug/agent><efficacy analysis><efficacy assessment><efficacy determination><efficacy evaluation><efficacy examination><enroll><ethnic diversity><ethnic minority><ethnic subgroup><ethnically diverse><ethnicity group><evaluate efficacy><evidence base><examine efficacy><experience><faces><facial><falls><follow up><follow-up><followed up><follower of religion Jewish><followup><group of color><homes><improved><individual of color><innovate><innovation><innovative><intervention arm><intervention therapy><metropolitan><minimal risk><mortality><neural control><neural regulation><neuromodulation><neuromodulatory><neuroregulation><non-drug therapy><non-drug treatment><nondrug therapy><nondrug treatment><novel><opiate therapy><opioid therapy><pain killer><pain medication><pain reduction><pain reliever><pain treatment><painkiller><patient population><people of color><person of color><population of color><post intervention><primary outcome><racial><racial background><racial minority><racial origin><racial population><racial subgroup><randomisation><randomization><randomized control trial><randomly assigned><reduce pain><sadness><satisfaction><secondary outcome><side effect><socio-demographics><sociodemographics><telehealth><transcranial direct current stimulation><treat chronic pain><treatment arm><treatment effect>