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Remote Electrical Stimulation for Pain and Depression in Cirrhosis

This study is looking into a treatment called Transcutaneous Electrical Acustimulation (TEA) for people with cirrhosis (a type of liver disease) who also experience chronic pain and depression. You would use a TEA device at home twice a day for 8 weeks. Some participants will receive the active TEA treatment, while others will receive a sham (inactive) version. The researchers want to see if this treatment is acceptable to patients and if it's practical to conduct a larger study. To join, you need to have cirrhosis, ongoing pain, and potentially depression, and be willing to use the TEA device. The study plans to enroll 30 participants.

Study design
This is an interventional study where 30 participants will be randomly assigned to receive either active Transcutaneous Electrical Acustimulation (TEA) or sham TEA.
What's involved
You would apply the TEA device at home twice a day for 45 minutes each time, over 8 weeks. You would also allow medical records to be collected and complete questionnaires.
Compensation
Not stated in the trial record.
Follow-up
The study measures acceptability and feasibility up to 10 weeks after the start of the treatment period.

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NCT06932783

Remote Electrical Stimulation for Pain and Depression Treatment in Cirrhosis

Active, Not Recruiting
NAAges 18+InterventionalTreatment
University of Michigan
~35 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:Transcutaneous Electrical Acustimulation (TEA)Sham Transcutaneous Electrical Acustimulation (TEA)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Acceptability Questionnaire at 10 weeks
Measured over 10 weeks
+5 more outcomes measured

Conditions

Cirrhosis

Explore related trials

Chronic PainCirrhosisDepression

Where it's being run

1 sites across 1 states
Michigan1

Study leadership

  • Elliot Tapper, MD · PRINCIPAL_INVESTIGATOR · University of Michigan

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Diagnosis of cirrhosis - must meet the criteria as outlined in the protocol
Chronic pain (Patient self-reports ≥ 4 on the 0-10 scale for \>50% of days within 3- months)
Depression (in at least half of participants) - must meet the criteria as outlined in the protocol
English speaking
Willing to use a Transcutaneous Electrical Acustimulation device

Exclusion

Dementia and/or severe cognitive impairment
Unable or unwilling to provide consent
Expected to undergo liver transplant in next 24 weeks
No email address
Deemed unsuitable by the study investigator

What this trial measures

  • Acceptability Questionnaire at 10 weeks10 weeks

    There are 7 questions that will be completed regarding the participant's experience with the study. There are six questions that participants will select strongly agree (5) - strongly disagree (1), with a range of 6-30. Additionally, participant's select from not very likely (1) -extremely likely (10). The last scale 1-10 asks "on a scale from 1-10, where 1 is not very likely and 10 is extremely likely, I am likely to recommend using the TEA device to a friend, colleague, or family member with cirrhosis and pain."

  • Feasibility based on the proportion of participants enrolled that were contactedEnrollment period (2 years)
  • Feasibility based on the Proportion of enrolled participants that dropout (overall and during run in)Run-in (-14 days to baseline) to 10 weeks
  • Feasibility based on time required to complete study assessmentsScreening - 10 weeks

    Time will be in minutes

  • Proportion of questionnaires completed at baseline and the final study visit (10 weeks)Baseline, 10 weeks
  • TEA usage during the intervention periodWeeks 1-8 of TEA treatment

    Time per day.