Clinical Trial

TENS in Scleroderma

Completed
View on ClinicalTrials.gov →
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.
Protocol Amendment History 6 changes
critical Trial completed 2026-08-14
critical Phase changed: Phase 1 -> not applicable 2026-08-14
critical Primary endpoint(s) modified 2026-08-14
notable Enrollment reduced: 16 -> 11 participants 2026-08-14
notable Primary completion moved earlier: 2026-02 -> 2025-06-02 2026-08-14
minor Completion moved earlier: 2026-05 -> 2025-06-30 2026-08-14
Trial Details
NCT Number NCT06646913
Lead Sponsor University of Michigan
Conditions Scleroderma, Gastroparesis, Systemic Sclerosis (SSc)
Enrollment 11 participants
Start Date 2024-10-01
Primary Completion 2025-06-02 (estimated)
Study Completion 2025-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-13