Chronic Pain Optimization and Management for Relief and Functionality With TEA in Cirrhosis

NCT07820917 | Not Yet Recruiting FDA Device

• 2 other identifiers: HUM002998321R01AT013417-01A1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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 (4)

• Retention

  Approximately day -14, day 1, and day 56

• Device adherence

  Reported as percent, reported from device utilization logs

  Approximately week 8

• Questionnaire completion

  Reported as percent

  Approximately week 8

• Acceptability of Intervention Measure (AIM) score

  AIM is a 6-item study-specific Likert battery with scores ranging from 0-5. Higher scores indicate lower acceptability.

  Approximately week 8 and week 12

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 an 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.

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

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)
• Willing to use a Transcutaneous Electrical Acustimulation (TEA) device
• Has access to Wi-Fi or a data plan
• Has access to a laptop, computer, tablet, or smartphone

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
• Model for End-Stage Liver Diseas (MELD) score \>25, or total bilirubin \>4.0 in a patient on hemodialysis
• Recent hospitalization (\>24 hours) or episode of hepatic encephalopathy within the preceding 30 days
• Implanted pacemaker/defibrillator, spinal implant, or cochlear implant
• Known allergy to adhesive tape/electrode materials
• Current active suicidal ideation, endorsed at screening (see Section 8.6)
• Currently pregnant (self-reported)

Sponsors & Collaborators

• University of Michigan: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• University of Pennsylvania: collaborator

Study Sites (2)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

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

Andrea MacMichael

CONTACT

734-232-4182; amacmi@umich.edu

Study Design

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

Model Details: This is an 8-week, randomized, double-blind, sham-controlled pilot trial of TEA across two academic medical centers, in preparation for a subsequent multicenter efficacy trial.

Study Record Dates

• First Submitted: September 9, 2026
• First Posted: September 15, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: September 16, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)