Remote Electrical Stimulation for Pain and Depression Treatment in Cirrhosis (RESTORE)

University of Michigan

Status: Begins enrollment this month

Conditions: Cirrhosis

Treatments: Device: Sham Transcutaneous Electrical Acustimulation (TEA); Device: Transcutaneous Electrical Acustimulation (TEA)

Study type: Interventional

Funder types: Other

Identifiers

NCT06932783

HUM00269546

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Transcutaneous Electrical Acustimulation (TEA)

Experimental group

Description:

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

Treatment:

Device: Transcutaneous Electrical Acustimulation (TEA)

TEA Sham

Sham Comparator group

Description:

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

Treatment:

Device: Sham Transcutaneous Electrical Acustimulation (TEA)