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

Plain Language Summary

Simplified for easier understanding

This study is testing a wearable device that delivers gentle electrical stimulation to the skin to help reduce both chronic pain and depression at the same time. It is a non-invasive, remote treatment that patients can use at home. **You may be eligible if...** - You have chronic pain that has lasted for at least 3 months - You also experience symptoms of depression - You are an adult (18 or older) - You are able to use a wearable device and participate remotely **You may NOT be eligible if...** - You have a pacemaker or other implanted electrical device - You have epilepsy or a history of seizures - You have skin conditions or wounds at the stimulation site - You are currently undergoing other electrical stimulation treatments - You have severe psychiatric conditions requiring immediate intervention Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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)