NCT06932783

Remote Electrical Stimulation for Pain and Depression Treatment in Cirrhosis

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cirrhosis

Interventions

Type	Name	Description
DEVICE	Transcutaneous 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).
DEVICE	Sham 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)

Timeline

• Start date: 2025-07-22
• Primary completion: 2027-07-01
• Completion: 2027-07-01
• First posted: 2025-04-17
• Last updated: 2026-03-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study