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Pain Reduction Using NEurostimulation (PRUNE) Study

Clinical Trial Details

The purpose of this study is to evaluate the usefulness of an at home small battery-operated device using a headband that delivers transcranial Direct Current Stimulation (tDCS) to see if it reduces pain in kidney disease patients receiving hemodialysis (HD) treatments.

The tDCS device is non-invasive (no surgical procedure is needed) and battery-operated and provides painless stimulation to focused areas on your head using a headband. There is minimal risk associated with using a tDCS device. It is categorized as investigational by the U.S. Food and Drug Administration (FDA), which means it is not yet approved by FDA and all trials using this device to-date have been deemed as posing non-significant risk.

This study aims to determine the benefits of using tDCS to treat pain because the current method of managing pain for people undergoing HD normally involves the use of medications that pose health risks. People that use tDCS in research studies can continue taking their medications and receive their other treatments as usual.

Prior to the start of the study, a research team member will provide instructions on how to use the device. This training will take place in each participants’ home and the research team member will answer all questions and ensure everyone is comfortable and ready to use the device at home.

Participants will then be “randomized” into one of two study groups: neurostimulation treatment (Group 1) or placebo treatment (Group 2). Placebo means that there is no real treatment (sham/fake). Randomization means that you are put into a group by chance. It is like flipping a coin and participants will have an equal chance of being placed in either group.

All participants will self-administer the device treatment for 8 weeks. After the first 20-minute session, the sessions will continue five times a week (Monday through Friday) for 8 consecutive weeks for a total of 40 sessions.

Participants will also complete a baseline survey (that will include questions about pain, medication use, mood, and quality of life), follow-up surveys throughout the study, as well as a medication look back. The medication look back will learn whether any of the medications taken to help manage pain have changed and to remind about recording pain medication use over a 5-day period. Participants will also complete questionnaires at weeks 5 more times (weeks 2, 8, 12, 16, and 26). All of these visits will be done over the phone or by videoconference.

Total study participation will last for a maximum of 7 months.

Key Eligibility: 

Inclusion Criteria:

  1. 21 years of age or older
  2. Diagnosis of end stage kidney disease (aka kidneys do not work) and receiving hemodialysis
  3. Montreal Cognitive Assessment adjusted score of greater than or equal to 18
  4. Pain for 3 months or longer, with a self-reported pain intensity of greater than or equal to 4 (on a 0-10 scale)
  5. Medically stable, as determined by clinician and defined as unlikely to undergo a substantial change in illness or treatment during the next 3 months

 Exclusion Criteria:

  1.  Active medical or major psychiatric illnesses that will impact pain or interfere with study procedures
  2. 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
  3. Use of another neurostimulation device (such as spinal cord stimulator, cardio-stimulator implanted cardioverter-defibrillator)
  4. Not able to respond to brief questionnaires and rating scales that will interfere with study procedures

Detailed eligibility will be discussed when reaching out to the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Patricia Kim
(212) 746-1758
pak2020@med.cornell.edu

Lower Manhattan

Contact(s)

Patricia Kim
(212) 746-1758
pak2020@med.cornell.edu

Queens

Contact(s)

Patricia Kim
(212) 746-1758
pak2020@med.cornell.edu

Brooklyn

Contact(s)

Patricia Kim
(212) 746-1758
pak2020@med.cornell.edu

Chelsea - Manhattan

Chelsea Clinical Trial Location

Contact(s)

Patricia Kim
(212) 746-1758
pak2020@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2107023793

ClinicalTrials.gov:

NCT05311956

Sponsor:

R01DK131050

Status

Open to Enrollment

Age Group

Adult

Sponsor