End Stage Kidney DiseasePRUNENCT05311956
Pain Reduction Using NEurostimulation Study
A study testing Active tDCS in people with End Stage Kidney Disease and Chronic Pain, run by Weill Medical College of Cornell University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- End Stage Kidney Disease, Chronic Pain
- What is being tested?
- Active tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Oct 2022to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
- Does not speak English or Spanish
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Rogosin Institute
New York, New York, 10021
NewYork-Presbyterian - Weill Cornell Medicine
New York, New York, 10065
About this study
Official title: Delivery of an At-Home Nonpharmacologic Intervention (Transcranial Neurostimulation) to Mitigate Pain in Patients With End Stage Kidney Disease Receiving Hemodialysis
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.
Read the 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
- Conditions
- End Stage Kidney Disease, Chronic Pain
- Being tested
- Active tDCS, Sham tDCS
- Keywords
- Dialysis, transcranial direct current stimulation (tDCS)
- Medical subject headings
- Kidney Failure, Chronic, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active tDCSDevice
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.
Sham tDCSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | 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). Receives: Device: Active tDCS |
| Sham Comparator | 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). Receives: Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in worst pain intensity over past 7 days
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.
Measured: Baseline, 8 weeks (at the end of intervention)
Secondary outcomes (10)
Change in worst pain intensity over past 7 days
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.
Measured: Baseline, 2 weeks (during intervention), 8 weeks (at the end of intervention), 12, 16, and 26 weeks post-baseline.
Change in average pain intensity over past 7 days (PROMIS pain intensity short form)
Pain intensity will be measured by PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Intensity - Short Form 3a. This 3-item instrument assesses how much a person hurts. The first two items assess pain intensity utilizing a 7-day recall period (items include the phrase "the past 7 days") while the last item asks patients to rate their pain intensity "right now." Respondents report their pain on a 5-point scale: 1=Had no pain, 2=Mild, 3=Moderate, 4=Severe, and 5=Very severe.
Measured: 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
Participants will be asked what pain and pain related medications they are taking including the dose of each medication and how often they take them. A worksheet will be personalized to each participant to minimize the amount of recording that participants have to do in this phase of the study. The Y axis will list the medication (if taken more than once a day, each time point will have its own line) while the X axis will have the dates these data need to be collected. The participant will indicate how many pills they took in the table itself. The total dose of each pain and pain-related medication taken over the 5-day recording periods will be compared.
Measured: 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)
Pain interference will be measured by PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference - Short Form 6b. This 6-item instrument measures the self-reported impact of pain on a person's life and assesses the extent to which pain may interfere with engagement with social, cognitive, emotional, physical, and recreational activities over a 7-day recall period. Pain Interference also incorporates items problem sleep and enjoyment in life, though the item bank only contains one sleep item. Respondents report levels of pain interference on a 5-point scale: 1=Not at all, 2=A little bit, 3=Somewhat, 4=Quite a bit, and 5=Very much.
Measured: 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)
Depressive Symptoms will be measured by PHQ-8 (Patient Health Questionnaire). This 8-item instruments measures symptoms of depression over the past 2 weeks such as, 'feeling down, depressed, or hopeless' or 'poor appetite or overeating'. Respondents report level of depression symptoms on a 4-point scale: 0=not at all, 1=Several days, 2=More than half the days, and 3=Nearly every day. The overall score range is 0 to 24 with a higher score indicating higher depressive symptoms.
Measured: Baseline, 2 weeks (during intervention), 8 weeks (at the end of intervention), 12, 16, and 26 weeks post-baseline.
Change in Quality of Life Questionnaire Score (WHOQOL-BREF)
Quality of Life will be measured by the Quality of Life Questionnaire (WHOQOL-BREF), a 26-item widely used and validated measure developed by the World Health Organization. Specific domains asked looking back over the last 2 weeks include physical health (e.g., enough energy for everyday life), psychological health (e.g., frequency of negative feelings), social relationships (e.g., satisfaction of support from friends), and environment (e.g., access to health services). Respondents answer each question on a 5-point scale and are transformed linearly to an overall adjusted score ranging from 0 to 100; with a higher score indicating higher quality of life.
Measured: 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
Satisfaction with the tDCS-TH device and procedure is assessed using the tDCS User Survey that includes 8 statements describing various aspects of user's experience, such as education and training on tDCS use, ease of the procedure, or user's interest in future use of the device. on the first 7 statements are rated on a 5-point scale with anchor points Strongly Agree- Strongly Disagree. The last question is an open ended question asking about challenges and ways to improve
Measured: 8 weeks (at the end of intervention)
Number of related adverse events
Occurrence of the number of related side effects and adverse events will be compared between groups.
Measured: Up to 26-weeks post-baseline
Number of probably related adverse events
Occurrence of the number of probably related side effects and adverse events will be compared between groups.
Measured: Up to 26-weeks post-baseline
Number of possibly related adverse events
Occurrence of the number of possibly related side effects and adverse events will be compared between groups.
Measured: Up to 26-weeks post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start24 Oct 2022
- Primary completion28 Jan 2026
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End Stage Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Metropolitan Jewish Health System, Rogosin Institute, Cornell University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- Cary Reid, MD, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05311956
- Sponsor's protocol ID
- 26-01029761frmly21-0702379
- Other IDs
- R01DK131050, 22048
- Acronym
- PRUNE
- Status last verified
- May 2026
- First submitted
- 28 Mar 2022
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Van Zyl J, Knotkova H, Kim P, Henderson CR Jr, Portenoy RK, Berman N, Frederic MW, Reid MC. Delivery of an at-home transcranial direct current stimulation intervention to mitigate pain in patients with end-stage kidney disease receiving hemodialysis (ESKD/HD). Front Pain Res (Lausanne). 2023 Apr 5;4:1132625. doi: 10.3389/fpain.2023.1132625. eCollection 2023.
PubMed 37092011
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delivery of an At-Home Nonpharmacologic Intervention (Transcranial Neurostimulation) to Mitigate Pain in Patients With End Stage Kidney Disease Receiving Hemodialysis
- ClinicalTrials.gov ID
- NCT05311956
- Acronym / sponsor ID
- PRUNE / 26-01029761frmly21-0702379
- Conditions
- End Stage Kidney Disease, Chronic Pain
- Keywords
- Dialysis, transcranial direct current stimulation (tDCS)
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Metropolitan Jewish Health System, Rogosin Institute, Cornell University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 24 Oct 2022 (actual)
- Primary completion
- 28 Jan 2026 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: Active tDCSPatients 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). |
| Sham Comparator | Sham comparator | Device: Sham tDCSSham 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). |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active tDCSThe 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. | Device | Experimental |
| Sham tDCSIn 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. | Device | Sham Comparator |
Primary outcome
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.
10 secondary outcomes
Change in worst pain intensity over past 7 days
Time frame: Baseline, 2 weeks (during intervention), 8 weeks (at the end of intervention), 12, 16, and 26 weeks post-baseline.
Change in average pain intensity over past 7 days (PROMIS pain intensity short form)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: Baseline, 2 weeks (during intervention), 8 weeks (at the end of intervention), 12, 16, and 26 weeks post-baseline.
Change in Quality of Life Questionnaire Score (WHOQOL-BREF)
Time frame: 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
Time frame: 8 weeks (at the end of intervention)
Number of related adverse events
Time frame: Up to 26-weeks post-baseline
Number of probably related adverse events
Time frame: Up to 26-weeks post-baseline
Number of possibly related adverse events
Time frame: Up to 26-weeks post-baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Derived from this study: PubMed 37092011Van Zyl J, Knotkova H, Kim P, Henderson CR Jr, Portenoy RK, Berman N, Frederic MW, Reid MC. Delivery of an at-home transcranial direct current stimulation intervention to mitigate pain in patients with end-stage kidney disease receiving hemodialysis (ESKD/HD). Front Pain Res (Lausanne). 2023 Apr 5;4:1132625. doi: 10.3389/fpain.2023.1132625. eCollection 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cary Reid, MD, PhD principal investigator
Weill Medical College of Cornell University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active tDCS in people with End Stage Kidney Disease and Chronic Pain, run by Weill Medical College of Cornell University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in worst pain intensity over past 7 days (time frame: Baseline, 8 weeks (at the end of intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05311956, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.