TENS in Scleroderma

Last updated: June 30, 2025
Sponsor: University of Michigan
Overall Status: Active - Recruiting

Phase

1

Condition

Gastroparesis

Scar Tissue

Scleroderma

Treatment

Transcutaneous Electrical Nerve Stimulation

Clinical Study ID

NCT06646913
HUM00246152
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Classification of Systemic Sclerosis according to the 2013 American College ofRheumatology and European League against Rheumatism classification criteria.

  2. Age >= 18 years

  3. English speaking.

  4. Participants who report moderate to severe symptoms of distension/bloating on UCLAScleroderma Clinical Trials Consortium Gastrointestinal Tract Instrument 2.0

  5. Stable GI specific therapy including prokinetics over the last 4 weeks.

Exclusion

Exclusion Criteria:

  1. Pregnancy, or currently lactating.

  2. A history of major abdominal surgery (other than cholecystectomy, appendectomy, ordeemed as non-major by the investigators)

  3. Unrelated active disorder which may involve abdominal pain, such as inflammatorybowel disease, diabetes or unstable thyroid disease.

  4. Known allergy to adhesive ECG electrodes.

  5. Known contraindications to TEA (e.g., cardiac pacemaker, epilepsy)

Study Design

Total Participants: 16
Treatment Group(s): 1
Primary Treatment: Transcutaneous Electrical Nerve Stimulation
Phase: 1
Study Start date:
October 01, 2024
Estimated Completion Date:
May 31, 2026

Connect with a study center

  • University of Michigan

    Ann Arbor, Michigan 48912
    United States

    Active - Recruiting

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