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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.
Inclusion Criteria:
Exclusion Criteria:
Detailed eligibility will be discussed when reaching out to the study team.