Remote Electrical Stimulation for Pain and Depression Treatment in Cirrhosis
Recruiting · NCT06932783 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Michigan
View the official record on ClinicalTrials.gov →Interventions studied
Sham Transcutaneous Electrical Acustimulation (TEA)Transcutaneous Electrical Acustimulation (TEA)
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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
Where it is running
1 location listed across 1 US state.
- University of Michigan - Ann Arbor, Michigan, United States