Could a headband zap away dialysis pain?
NCT ID NCT05311956
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a small, battery-powered headband that delivers a gentle electrical pulse to the scalp to help reduce chronic pain in people with end-stage kidney disease who are on dialysis. About 125 adults will use the device at home and report their pain levels. The goal is to see if this non-drug approach can make daily life less painful.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 125 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2022
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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NewYork-Presbyterian - Weill Cornell Medicine
New York, New York, 10065, United States
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The Rogosin Institute
New York, New York, 10021, United States
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Other studies related to the condition(s) this trial covers.
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