Remote Electrical Stimulation for Pain and Depression Treatment in Cirrhosis

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT06932783
Status
Recruiting
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Conditions

  • Cirrhosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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).
  • 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 Details

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.

Key Dates

Start date
Jul 22, 2025
Status verified
Jul 2025
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Transcutaneous Electrical Acustimulation (TEA)
    Participants will have a two-week run-in period and then 8 weeks of treatment.
  • Sham Comparator: TEA Sham
    Participants will have a two-week run-in period and then 8 weeks of sham treatment.

Primary Outcome Measure

Acceptability Questionnaire at 10 weeks [ Time Frame: 10 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
Melanie Tapper
[email protected]
734-232-4182
Elliot Tapper, MD (PRINCIPAL_INVESTIGATOR)

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University of Michigan· Ann Arbor, MI

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