Electrical Stimulation for Pain and Depression in Liver Cirrhosis

(RESTORE Trial)

Overseen By Melanie Herschel

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Dementia, Cognitive impairment, Liver transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

30 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{1 2 6 7 8}

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

I have chronic pain rated 4 or higher for most days in the past 3 months.

Depression (in at least half of participants) - must meet the criteria as outlined in the protocol

English speaking

Exclusion Criteria

Deemed unsuitable by the study investigator

Unable or unwilling to provide consent

No email address

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Run-in Period

Participants undergo a two-week run-in period before starting treatment

2 weeks

Treatment

Participants receive either Transcutaneous Electrical Acustimulation (TEA) or sham TEA for 8 weeks

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sham Transcutaneous Electrical Acustimulation (TEA)
• Transcutaneous Electrical Acustimulation (TEA)

Trial Overview The study compares Transcutaneous Electrical Acustimulation (TEA), which delivers electrical pulses to relieve pain and treat depression, against sham TEA—a placebo version without active stimulation—to determine its effectiveness in patients with cirrhosis.

How Is the Trial Designed?

Group I: Transcutaneous Electrical Acustimulation (TEA) Experimental Treatment 1 Intervention

Participants will have a two-week run-in period and then 8 weeks of treatment.

Group II: TEA Sham Placebo Group 1 Intervention

Participants will have a two-week run-in period and then 8 weeks of sham treatment.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Published Research Related to This Trial

In a study involving 23 patients with chronic pancreatitis, neither electroacupuncture nor transcutaneous electric nerve stimulation (TENS) provided significant pain relief compared to sham treatments.

The findings suggest that these alternative therapies do not effectively replace or enhance standard medical treatments for managing pain in pancreatitis patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture and transcutaneous electric nerve stimulation in the treatment of pain associated with chronic pancreatitis. A randomized study. Ballegaard, S., Christophersen, SJ., Dawids, SG., et al.[2019]

In a pilot study involving 48 inpatients undergoing opioid detoxification, those receiving active transcutaneous electric acupoint stimulation (TEAS) showed significantly lower rates of drug use (35% vs. 77%) compared to those receiving sham treatment by two weeks post-discharge.

Participants in the active TEAS group also reported greater improvements in pain interference and physical health, suggesting that TEAS is a feasible and effective adjunctive treatment for enhancing recovery during opioid detoxification.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of transcutaneous electric acupoint stimulation as adjunctive treatment for opioid detoxification. Meade, CS., Lukas, SE., McDonald, LJ., et al.[2022]

This multicenter trial will evaluate the efficacy of transcutaneous electrical acupoint stimulation (TEAS) combined with opioid drugs in treating moderate to severe cancer-related pain in 160 patients over a three-week period, aiming to improve pain management and reduce opioid side effects.

The study will assess primary outcomes through changes in pain scores and morphine dosage, while also examining the potential benefits of TEAS on immune function and overall quality of life, addressing a significant gap in current cancer pain management research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the analgesic effect and advantage of transcutaneous electrical acupoint stimulation combined with opioid drugs for moderate to severe cancer-related pain: a study protocol for a randomized controlled trial. Liang, Y., Bao, G., Gong, L., et al.[2020]

This clinical trial will evaluate the effectiveness of transcutaneous electrical acupoint stimulation (TEAS) combined with opioids in managing moderate to severe cancer-related pain in 104 patients with hepatocellular carcinoma (HCC).

The study aims to assess pain relief and quality of life improvements using various measures, including the Numerical Rating Scale (NRS) and the Brief Pain Inventory (BPI), over a treatment period of one week.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Electrical Acupoint Stimulation for Moderate to Severe Pain in Hepatocellular Carcinoma: A Protocol for a Randomized Controlled Trial. Wu, P., Zhu, L., Zheng, SY., et al.[2022]

Citations

1. withpower.com withpower.com/trial/phase-liver-cirrhosis-5-2025-d3fa9

Electrical Stimulation for Pain and Depression in Liver ... Research shows that Transcutaneous Electrical Acupoint Stimulation (TEAS), similar to TEA, has been effective in reducing pain in various conditions, including ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9271907/

Transcutaneous Electrical Acupoint Stimulation for ... Previous studies have shown that transcutaneous electrical acupoint stimulation (TEAS) is effective in treating patients with acute or chronic pain.

3. tandfonline.com tandfonline.com/doi/abs/10.1080/17434440.2025.2508872

Transcutaneous electric nerve stimulation in restless leg ... Transcutaneous Electric Nerve Stimulation improved RLS symptoms, sleep quality, anxiety, depression, and overall quality of life in cirrhosis patients.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06721572

Role of Home-Based Transcutaneous Electrical ... TEA transmits a weak electrical current using electrodes placed at acupoints and has shown to safely reduce pain in other gastrointestinal conditions.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1094715924006482

Integrative Effects of Transcutaneous Electrical ... TEA at PC6 and ST36 accelerates the post-ERCP recovery, reflected as the improvement in GI motility and amelioration of abdominal pain.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06932783

NCT06932783 | Remote Electrical Stimulation for Pain and ... 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 ...

7. dovepress.com dovepress.com/effects-of-transcutaneous-electrical-acustimulation-on-patients-with-f-peer-reviewed-fulltext-article-JPR

Effects of Transcutaneous Electrical Acustimulation on ... This study aims to evaluate the efficacy and mechanisms of Transcutaneous Electrical Acustimulation treatment for Fibromyalgia Syndrome.

8. tandfonline.com tandfonline.com/doi/full/10.2147/JPR.S456874

Full article: Treatment of Moderate-to-Severe Pain in ... This trial aimed to analyze the clinical efficacy of Transcutaneous electrical acupoint stimulation (TEAS) in patients of HCC with severe pain.