CirrhosisRESTORENCT06932783
Remote Electrical Stimulation for Pain and Depression Treatment in Cirrhosis
A study testing Transcutaneous Electrical Acustimulation (TEA) in people with Cirrhosis, run by University of Michigan at 1 site 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
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2025to Jul 2027
- 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)
- 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
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- 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 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 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)
| 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.
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."
Measured: 10 weeks
Feasibility based on the proportion of participants enrolled that were contacted
Measured: Enrollment period (2 years)
Feasibility based on the Proportion of enrolled participants that dropout (overall and during run in)
Measured: Run-in (-14 days to baseline) to 10 weeks
Feasibility based on time required to complete study assessments
Time will be in minutes
Measured: Screening - 10 weeks
Proportion of questionnaires completed at baseline and the final study visit (10 weeks)
Measured: Baseline, 10 weeks
TEA usage during the intervention period
Time per day.
Measured: Weeks 1-8 of TEA treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start22 Jul 2025
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (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
- Participants will be randomized 1:1 to either TEA or sham-control. At least half of the participants will have depression per study definition.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- 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
- NCT06932783
- Sponsor's protocol ID
- HUM00269546
- Acronym
- RESTORE
- Status last verified
- Aug 2026
- First submitted
- 10 Apr 2025
- Last updated
- 1 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 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RESTORE: Remote Electrical Stimulation for Pain and Depression Treatment in Cirrhosis
- ClinicalTrials.gov ID
- NCT06932783
- Acronym / sponsor ID
- RESTORE / HUM00269546
- Conditions
- Cirrhosis
- Keywords
- Transcutaneous Electrical Acustimulation, Chronic Pain, Depression
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 22 Jul 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 17 Apr 2025 (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
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomized 1:1 to either TEA or sham-control. At least half of the participants will have depression per study definition.
| 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)
- 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
Key exclusion criteria (5 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 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 | 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 (approximately 9-10 weeks) | Device | TEA Sham |
Primary outcome
Acceptability Questionnaire at 10 weeks
Time frame: 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."
Feasibility based on the proportion of participants enrolled that were contacted
Time frame: Enrollment period (2 years)
Feasibility based on the Proportion of enrolled participants that dropout (overall and during run in)
Time frame: Run-in (-14 days to baseline) to 10 weeks
Feasibility based on time required to complete study assessments
Time frame: Screening - 10 weeks
Time will be in minutes
Proportion of questionnaires completed at baseline and the final study visit (10 weeks)
Time frame: Baseline, 10 weeks
TEA usage during the intervention period
Time frame: Weeks 1-8 of TEA treatment
Time per day.
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 1 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. This study is not recruiting at the moment.
Elliot Tapper, MD principal investigator
University of Michigan
1 site 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 1 site 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 5 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: under way, not looking for participants, as of the sponsor's last update on 1 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 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability Questionnaire at 10 weeks (time frame: 10 weeks). The study lists 6 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 1 Sep 2026.