Remote Electrical Stimulation for Pain and Depression Treatment in Cirrhosis
NCT ID: NCT06932783
Last Updated: 2025-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2025-07-22
2027-07-31
Brief Summary
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Enrolled participants on this feasibility study will be randomized to Transcutaneous Electrical Acustimulation (TEA) or sham TEA.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Transcutaneous Electrical Acustimulation (TEA)
Participants will have a two-week run-in period and then 8 weeks of treatment.
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).
TEA Sham
Participants will have a two-week run-in period and then 8 weeks of sham treatment.
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)
Interventions
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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 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)
Eligibility Criteria
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Inclusion Criteria
* 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
* Unable or unwilling to provide consent
* Expected to undergo liver transplant in next 24 weeks
* No email address
* Deemed unsuitable by the study investigator
18 Years
ALL
No
Sponsors
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University of Michigan
OTHER
Responsible Party
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Elliot B. Tapper
Associate Professor of Internal Medicine
Principal Investigators
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Elliot Tapper, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan
Ann Arbor, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HUM00269546
Identifier Type: -
Identifier Source: org_study_id
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