Remote Electrical Stimulation for Pain and Depression Treatment in Cirrhosis

Not Applicable

Not yet recruiting

• Conditions: Cirrhosis

• Registration Number: NCT06932783
• Lead Sponsor: University of Michigan

Brief Summary

This study is being done to better understand how the study team can treat pain for people with cirrhosis and depression.

Enrolled participants on this feasibility study will be randomized to Transcutaneous Electrical Acustimulation (TEA) or sham TEA.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-10
• Study First Submitted QC: 2025-04-10
• Last Update Submitted: 2025-04-10
• Study First Posted: 2025-04-17
• Last Update Posted: 2025-04-17
• Study Start: 2025-06
• Primary Completion: 2027-06
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Acceptability Questionnaire at 10 weeks	10 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 contacted	Enrollment 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 assessments	Screening - 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 period	Weeks 1-8 of TEA treatment	Time per day.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States