RECRUITING

Remote Electrical Stimulation for Pain and Depression Treatment in Cirrhosis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-07-22
Study Completion:2027-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06932783

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of cirrhosis - must meet the criteria as outlined in the protocol
  2. * Chronic pain (Patient self-reports ≥ 4 on the 0-10 scale for \>50% of days within 3- months)
  3. * Depression (in at least half of participants) - must meet the criteria as outlined in the protocol
  4. * English speaking
  5. * Willing to use a Transcutaneous Electrical Acustimulation device
  1. * Dementia and/or severe cognitive impairment
  2. * Unable or unwilling to provide consent
  3. * Expected to undergo liver transplant in next 24 weeks
  4. * No email address
  5. * Deemed unsuitable by the study investigator

Contacts and Locations

Study Contact

Tasnuva Tarannum
CONTACT
734-232-4182
tasnuvat@med.umich.edu
Samantha Nikirk
CONTACT
734-232-4182
samjwalk@med.umich.edu

Principal Investigator

Elliot Tapper, MD
PRINCIPAL_INVESTIGATOR
University of Michigan

Study Locations (Sites)

University of Michigan
Ann Arbor, Michigan, 48109
United States

Collaborators and Investigators

Sponsor: University of Michigan

  • Elliot Tapper, MD, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-22
Study Completion Date2027-07

Study Record Updates

Study Start Date2025-07-22
Study Completion Date2027-07

Terms related to this study

Keywords Provided by Researchers

  • Transcutaneous Electrical Acustimulation
  • Chronic Pain
  • Depression

Additional Relevant MeSH Terms

  • Cirrhosis