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RECRUITING
NCT06646913
PHASE1

TENS in Scleroderma

Sponsor: University of Michigan

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.

Official title: Transcutaneous Electrical Nerve Stimulation in Scleroderma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

16

Start Date

2024-10-01

Completion Date

2026-05

Last Updated

2025-07-03

Healthy Volunteers

No

Interventions

DEVICE

Transcutaneous Electrical Nerve Stimulation

Patients will utilize the TENS device for 45 minutes, two times per day for the 4 week treatment period.

Locations (1)

University of Michigan

Ann Arbor, Michigan, United States