Remote electrical stimulation to treat pain and depression in cirrhosis
RESTORE: Remote Electrical Stimulation for Pain and Depression Treatment in Cirrhosis
NA · University of Michigan · NCT06932783
This project will see if a home transcutaneous electrical acustimulation (TEA) device can help reduce chronic pain and depression in people with cirrhosis.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Michigan (other) |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT06932783 on ClinicalTrials.gov |
What this trial studies
This is a randomized, sham-controlled feasibility trial run at the University of Michigan enrolling adults with cirrhosis and chronic pain, with at least half the participants having coexisting depression. Enrolled participants will be randomized to active transcutaneous electrical acustimulation (TEA) or a sham TEA device and will use the device remotely at home. The study will collect patient-reported pain and mood measures along with feasibility metrics such as adherence, tolerability, and ability to complete remote procedures. Findings will guide whether a larger trial is warranted and help refine remote-delivery methods.
Who should consider this trial
Good fit: Adults with a clinical diagnosis of cirrhosis who report chronic pain (≥4/10 on most days over the past three months), can speak English, have email access, and are willing to use a TEA device are ideal candidates.
Not a fit: People with severe cognitive impairment or dementia, those unable or unwilling to consent or use the device, or those expected to undergo liver transplant within 24 weeks are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, TEA could provide a non-drug, home-based option to reduce pain and depressive symptoms for people with cirrhosis.
How similar studies have performed: Related noninvasive electrical stimulation approaches (like TENS and other TEA studies) have shown modest benefit for pain and mood in some other patient groups, but applying TEA specifically in cirrhosis is novel and not yet proven.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Ann Arbor, Michigan
- University of Michigan — Ann Arbor, Michigan, United States (RECRUITING)
Study contacts
- Principal investigator: Elliot Tapper, MD — University of Michigan
- Study coordinator: Tasnuva Tarannum
- Email: tasnuvat@med.umich.edu
- Phone: 734-232-4182
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cirrhosis, Transcutaneous Electrical Acustimulation, Chronic Pain, Depression