Recruiting NCT06932783
Remote Electrical Stimulation for Pain and Depression Treatment in Cirrhosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcutaneous Electrical Acustimulation (TEA), Sham Transcutaneous Electrical Acustimulation (TEA).
- Who it may be relevant to
- Registry conditions: Cirrhosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
RESTORE: Remote Electrical Stimulation for Pain and Depression Treatment in Cirrhosis
Overview
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.
Interventions
- Device 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 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)
Primary outcome measures
- Acceptability Questionnaire at 10 weeks [Time frame: 10 weeks]
- 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]
- 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]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Michigan — Ann Arbor
Identifiers
NCT: NCT06932783 · HUM00269546