CirrhosisCOMFORTNCT07820917
Chronic Pain Optimization and Management for Relief and Functionality With TEA in Cirrhosis
A study testing Transcutaneous Electrical Acustimulation (TEA) in people with Cirrhosis, run by University of Michigan at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis
- What is being tested?
- Transcutaneous Electrical Acustimulation (TEA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2026to Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
University of Michigan
Ann Arbor, Michigan, 48109
Melanie Tapper, 734-232-4182, etapper@umich.edu
Elliot Tapper, MD
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Richard Mason, PharmD, 215-349-8986, Richard.Mason@pennmedicine.upenn.edu
Jacqueline Theroux, MPH, 215-662-3904, Jacqueline.Theroux@pennmedicine.upenn.edu
About this study
Official title: COMFORT: Chronic Pain Optimization and Management for Relief and Functionality With TEA 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.
- Conditions
- Cirrhosis
- Being tested
- Transcutaneous Electrical Acustimulation (TEA), Sham Transcutaneous Electrical Acustimulation (TEA)
- Keywords
- Transcutaneous Electrical Acustimulation, Chronic Pain, Depression
- Medical subject headings
- Fibrosis, Chronic Pain, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous Electrical Acustimulation (TEA) | Experimental | Participants will have a two-week run-in period and then 8 weeks of treatment. Receives: 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. Receives: Device: Sham Transcutaneous Electrical Acustimulation (TEA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention
Measured: Approximately day -14, day 1, and day 56
Device adherence
Reported as percent, reported from device utilization logs
Measured: Approximately week 8
Questionnaire completion
Reported as percent
Measured: 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.
Measured: Approximately week 8 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), University of Pennsylvania
- Responsible party
- Principal investigator, Elliot B. Tapper, University of Michigan
- Investigators
- Elliot Tapper, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07820917
- Sponsor's protocol ID
- HUM00299832
- Other IDs
- 1R01AT013417-01A1
- Acronym
- COMFORT
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMFORT: Chronic Pain Optimization and Management for Relief and Functionality With TEA in Cirrhosis
- ClinicalTrials.gov ID
- NCT07820917
- Acronym / sponsor ID
- COMFORT / HUM00299832
- Conditions
- Cirrhosis
- Keywords
- Transcutaneous Electrical Acustimulation, Chronic Pain, Depression
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), University of Pennsylvania
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 15 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous Electrical Acustimulation (TEA) | Experimental | Device: Transcutaneous Electrical Acustimulation (TEA)Participants will have a two-week run-in period and then 8 weeks of treatment. |
| TEA Sham | Sham comparator | Device: Sham Transcutaneous Electrical Acustimulation (TEA)Participants will have a two-week run-in period and then 8 weeks of sham treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 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. | Device | Transcutaneous Electrical Acustimulation (TEA) |
| 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 | Device | TEA Sham |
Primary outcome
Retention
Time frame: Approximately day -14, day 1, and day 56
Device adherence
Time frame: Approximately week 8
Reported as percent, reported from device utilization logs
Questionnaire completion
Time frame: Approximately week 8
Reported as percent
Acceptability of Intervention Measure (AIM) score
Time frame: Approximately week 8 and week 12
AIM is a 6-item study-specific Likert battery with scores ranging from 0-5. Higher scores indicate lower acceptability.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elliot Tapper, MD principal investigator
University of Michigan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Electrical Acustimulation (TEA) in people with Cirrhosis, run by University of Michigan at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea MacMichael (734-232-4182, amacmi@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention (time frame: Approximately day -14, day 1, and day 56). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026; AzTrials last refreshed its copy on 27 Oct 2026.