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NCT Number: NCT06932783

Remote Electrical Stimulation for Pain and Depression Treatment in Cirrhosis

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.

Recruiting

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Key information

Conditions

Cirrhosis Behavior Behavioral Symptoms Chronic Pain Depression Fibrosis Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location status: Recruiting

Location contact

Elliot Tapper, MD

PRINCIPAL_INVESTIGATOR

Melanie Tapper

CONTACT

[email protected]

734-232-4182

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcutaneous Electrical Acustimulation (TEA)

Device

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).

Sham Transcutaneous Electrical Acustimulation (TEA)

Device

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 outcomes

  1. Acceptability Questionnaire at 10 weeks

    Time frame: 10 weeks

    There are 7 questions that will be completed regarding the participant's experience with the study. There are six questions that participants will select strongly agree (5) - strongly disagree (1), with a range of 6-30. Additionally, participant's select from not very likely (1) -extremely likely (10).

    The last scale 1-10 asks "on a scale from 1-10, where 1 is not very likely and 10 is extremely likely, I am likely to recommend using the TEA device to a friend, colleague, or family member with cirrhosis and pain."

  2. Feasibility based on the proportion of participants enrolled that were contacted

    Time frame: Enrollment period (2 years)

  3. 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

  4. Feasibility based on time required to complete study assessments

    Time frame: Screening - 10 weeks

    Time will be in minutes

  5. Proportion of questionnaires completed at baseline and the final study visit (10 weeks)

    Time frame: Baseline, 10 weeks

  6. TEA usage during the intervention period

    Time frame: Weeks 1-8 of TEA treatment

    Time per day.

Study contacts

Contact information is provided by the study sponsor or research team.

Samantha Nikirk

CONTACT

[email protected]

734-232-4182

Tasnuva Tarannum

CONTACT

[email protected]

734-232-4182

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

RESTORE: Remote Electrical Stimulation for Pain and Depression Treatment in Cirrhosis

Acronym: RESTORE

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 17, 2025
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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