Actively Recruiting
TENS in Scleroderma
Led by University of Michigan · Updated on 2025-07-03
16
Participants Needed
1
Research Sites
82 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
TENS in Scleroderma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Systemic Sclerosis according to the 2013 American College of Rheumatology and European League against Rheumatism criteria
- Age 18 years or older
- English speaking
- Moderate to severe symptoms of distension or bloating reported on the UCLA Scleroderma Clinical Trials Consortium Gastrointestinal Tract Instrument 2.0
- Stable gastrointestinal therapy including prokinetics for at least 4 weeks prior
You will not qualify if you...
- Pregnant or currently breastfeeding
- History of major abdominal surgery (except cholecystectomy, appendectomy, or surgery deemed non-major by investigators)
- Active disorders causing abdominal pain unrelated to Scleroderma, such as inflammatory bowel disease, diabetes, or unstable thyroid disease
- Known allergy to adhesive ECG electrodes
- Known contraindications to transcutaneous electrical acustimulation, including having a cardiac pacemaker or epilepsy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Michigan
Ann Arbor, Michigan, United States, 48912
Actively Recruiting
Research Team
D
Dinesh Khanna, MD, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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