NCT06646913

TENS in Scleroderma

Transcutaneous Electrical Nerve Stimulation in Scleroderma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Scleroderma
• Gastroparesis
• Systemic Sclerosis (SSc)

Interventions

Type	Name	Description
DEVICE	Transcutaneous Electrical Nerve Stimulation	Patients will utilize the TENS device for 45 minutes, two times per day for the 4 week treatment period.

Timeline

• Start date: 2024-10-01
• Primary completion: 2026-02-01
• Completion: 2026-05-01
• First posted: 2024-10-17
• Last updated: 2025-07-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study