Electrical Stimulation for Pain and Depression in Liver Cirrhosis
(RESTORE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to explore how electrical stimulation, using a small device that sends mild electrical pulses, can help treat pain and depression in people with liver cirrhosis. Participants will receive either the real treatment, Transcutaneous Electrical Acustimulation (TEA), or a sham (inactive) version to compare results. This trial suits those with cirrhosis who frequently experience chronic pain and have symptoms of depression. Participants should feel comfortable using an electrical stimulation device and be able to communicate in English. As an unphased trial, this study offers participants the chance to contribute to innovative research that could improve treatment options for symptoms related to liver cirrhosis.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. Please consult with the study team for guidance.
What prior data suggests that Transcutaneous Electrical Acustimulation (TEA) is safe for treating pain and depression in liver cirrhosis?
Research shows that Transcutaneous Electrical Acustimulation (TEA) is generally easy for patients to handle. Studies indicate that TEA is noninvasive, meaning it doesn't involve breaking the skin, and it doesn't increase the risk of infection. This makes it safer than treatments that do break the skin. Additionally, similar treatments like TEAS have effectively reduced pain without causing serious side effects.
Although specific information about TEA's side effects in patients with liver cirrhosis is limited, related studies suggest it is a low-risk option. These findings should reassure those considering joining a TEA trial, as they indicate the treatment is gentle on the body and usually doesn't cause major side effects.12345Why are researchers excited about this trial?
Researchers are excited about Transcutaneous Electrical Acustimulation (TEA) for managing pain and depression in liver cirrhosis because it offers a non-invasive and drug-free alternative. Unlike traditional medications that can have side effects and potential interactions, especially in patients with liver conditions, TEA uses gentle electrical stimulation to potentially alleviate symptoms. This approach is distinct because it targets specific nerve pathways to influence brain activity and pain perception, offering a novel mechanism of action that could complement or enhance existing treatments.
What evidence suggests that Transcutaneous Electrical Acustimulation (TEA) is effective for pain and depression in liver cirrhosis?
Research shows that Transcutaneous Electrical Acupoint Stimulation (TEAS), similar to Transcutaneous Electrical Acustimulation (TEA), can effectively reduce pain in various conditions. It has helped with both short-term and long-term pain. In this trial, participants will receive either TEA or a sham treatment. TEA sends a gentle electrical current through the skin at specific body points, safely easing pain related to digestive issues. Studies have also found that similar electrical stimulation methods improved symptoms like anxiety and depression in people with liver cirrhosis. These findings suggest that TEA might effectively treat pain and depression in patients with liver cirrhosis.12678
Who Is on the Research Team?
Elliot Tapper, MD
Principal Investigator
University of Michigan
Are You a Good Fit for This Trial?
This trial is for English-speaking adults with cirrhosis who suffer from chronic pain and, in some cases, depression. Participants must rate their pain at 4 or higher on a scale of 0-10 for most days over the past three months. They should be willing to use an electrical stimulation device but not expecting a liver transplant within the next six months.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Run-in Period
Participants undergo a two-week run-in period before starting treatment
Treatment
Participants receive either Transcutaneous Electrical Acustimulation (TEA) or sham TEA for 8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Sham Transcutaneous Electrical Acustimulation (TEA)
- Transcutaneous Electrical Acustimulation (TEA)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Michigan
Lead Sponsor