RECRUITING

TENS in Scleroderma

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Conditions

SclerodermaGastroparesisSystemic Sclerosis (SSc)TENSPilot StudySystemic Sclerosis

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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

The goal of this pilot study is to assess the acceptability of the transcutaneous electrical acustimulation (TEA) device in treating Scleroderma-related gastroparesis. The main objective is: To evaluate the acceptability of TEA as an intervention for alleviating symptoms of distension and bloating in individuals diagnosed with Scleroderma. Participants will be provided with the TEA devices that will be applied to the skin for a total of 45 minutes twice daily after meals. Participants will be asked to fill out both daily diaries and biweekly questionnaires to assess for improvement in the gastroparesis symptoms. Participants will also be asked to complete the daily diaries in addition weekly questionnaires during a 4 week post-treatment follow-up period.

Official Title

Transcutaneous Electrical Nerve Stimulation in Scleroderma

Quick Facts

Study Start:2024-10-01
Study Completion:2026-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06646913

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. 1. Classification of Systemic Sclerosis according to the 2013 American College of Rheumatology and European League against Rheumatism classification criteria.
  2. 2. Age \>= 18 years
  3. 3. English speaking.
  4. 4. Participants who report moderate to severe symptoms of distension/bloating on UCLA Scleroderma Clinical Trials Consortium Gastrointestinal Tract Instrument 2.0
  5. 5. Stable GI specific therapy including prokinetics over the last 4 weeks.
  1. 1. Pregnancy, or currently lactating.
  2. 2. A history of major abdominal surgery (other than cholecystectomy, appendectomy, or deemed as non-major by the investigators)
  3. 3. Unrelated active disorder which may involve abdominal pain, such as inflammatory bowel disease, diabetes or unstable thyroid disease.
  4. 4. Known allergy to adhesive ECG electrodes.
  5. 5. Known contraindications to TEA (e.g., cardiac pacemaker, epilepsy)

Contacts and Locations

Study Contact

Dinesh Khanna, MD, MSc
CONTACT
734-936-5615
khannad@med.umich.edu

Study Locations (Sites)

University of Michigan
Ann Arbor, Michigan, 48912
United States

Collaborators and Investigators

Sponsor: 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 Date2024-10-01
Study Completion Date2026-05

Study Record Updates

Study Start Date2024-10-01
Study Completion Date2026-05

Terms related to this study

Keywords Provided by Researchers

  • TENS
  • Scleroderma
  • Gastroparesis
  • Pilot Study
  • Systemic Sclerosis

Additional Relevant MeSH Terms

  • Scleroderma
  • Gastroparesis
  • Systemic Sclerosis (SSc)