RecruitingNot ApplicableNCT06932783

Remote Electrical Stimulation for Pain and Depression Treatment in Cirrhosis

RESTORE: Remote Electrical Stimulation for Pain and Depression Treatment in Cirrhosis

Sponsor

University of Michigan

Enrollment

30 participants

Start Date

Jul 22, 2025

Study Type

INTERVENTIONAL

Conditions

Cirrhosis

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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 Criteria5

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

Interventions

DEVICETranscutaneous Electrical Acustimulation (TEA)

Participant will apply TEA at home twice a day (approximately 45 minutes am/pm) for 8 weeks. The top electrode will be placed at ST36 (via acupuncture point) and the electrode patch will be placed vertically. Additionally, participants will agree to allow medical records to be collected, complete various surveys and have follow-up after treatment (approximately 9-10 weeks).

DEVICESham Transcutaneous Electrical Acustimulation (TEA)

Participant will apply sham TEA at home twice a day (approximately 45 minutes am/pm) for 8 weeks. Sham TEA will be performed via one point on the leg and not on any meridian or acupoints that were used in previous gastrointestinal studies and did not yield any significant effects. Additionally, participants will agree to allow medical records to be collected, complete various surveys and have follow-up after treatment (approximately 9-10 weeks)