Remote Electrical Stimulation for Pain and Depression Treatment in Cirrhosis (RESTORE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cirrhosis
• Intervention / Treatment: Device: Transcutaneous Electrical Acustimulation (TEA); Device: Sham Transcutaneous Electrical Acustimulation (TEA)

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Samantha Nikirk; Phone Number: 734-232-4182; Email: samjwalk@med.umich.edu
• Study Contact Backup: Name: Tasnuva Tarannum; Phone Number: 734-232-4182; Email: tasnuvat@med.umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
      • Principal Investigator: Elliot Tapper, MD
      • Contact: Melanie Tapper; Phone Number: 734-232-4182; Email: etapper@umich.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transcutaneous Electrical Acustimulation (TEA); Participants will have a two-week run-in period and then 8 weeks of treatment.	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).
Sham Comparator: TEA Sham; Participants will have a two-week run-in period and then 8 weeks of sham treatment.	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability Questionnaire at 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."	10 weeks
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	Time will be in minutes	Screening - 10 weeks
Proportion of questionnaires completed at baseline and the final study visit (10 weeks)		Baseline, 10 weeks
TEA usage during the intervention period	Time per day.	Weeks 1-8 of TEA treatment

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Elliot Tapper, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: April 10, 2025
• First Submitted That Met QC Criteria: April 10, 2025
• First Posted (Actual): April 17, 2025

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Depression; Chronic Pain; Transcutaneous Electrical Acustimulation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathologic Processes; Behavioral Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Chronic Pain; Depression; Fibrosis
• Other Study ID Numbers: HUM00269546

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No