Remote Electrical Stimulation for Pain and Depression Treatment in Cirrhosis

NCT06932783 | Recruiting FDA Device

• 1 other identifier: HUM00269546
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cirrhosis

Keywords

Transcutaneous Electrical Acustimulation; Chronic Pain; Depression

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Transcutaneous Electrical Acustimulation (TEA)

EXPERIMENTAL

Participants will have a two-week run-in period and then 8 weeks of treatment.

Device: Transcutaneous Electrical Acustimulation (TEA)

TEA Sham

SHAM COMPARATOR

Participants will have a two-week run-in period and then 8 weeks of sham treatment.

Device: Sham Transcutaneous Electrical Acustimulation (TEA)

Interventions

Transcutaneous Electrical Acustimulation (TEA) DEVICE

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).

Transcutaneous Electrical Acustimulation (TEA)

Sham Transcutaneous Electrical Acustimulation (TEA) DEVICE

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)

TEA Sham

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Fibrosis; Chronic Pain; Depression

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Elliot Tapper, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tasnuva Tarannum

CONTACT

734-232-4182; tasnuvat@med.umich.edu

Samantha Nikirk

CONTACT

734-232-4182; samjwalk@med.umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Internal Medicine

Model Details: Participants will be randomized 1:1 to either TEA or sham-control. At least half of the participants will have depression per study definition.

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 17, 2025
• Study Start: July 22, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 6, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)