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Device

TENS for Scleroderma

Phase 1
Recruiting
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age >= 18 years
Stable GI specific therapy including prokinetics over the last 4 weeks
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 months
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to test if a device called transcutaneous electrical acustimulation (TEA) can help with stomach problems in people with Scleroderma. Participants will use the TEA

Who is the study for?
This trial is for individuals with Scleroderma experiencing gastroparesis symptoms like bloating and distension. Participants will use a TEA device after meals and report their symptoms regularly.
What is being tested?
The study tests the acceptability of Transcutaneous Electrical Nerve Stimulation (TENS) to ease gastroparesis symptoms in Scleroderma patients, using devices applied to the skin for 45 minutes twice daily.
What are the potential side effects?
Potential side effects may include skin irritation at the site of application, muscle twitching, or discomfort during TENS treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
My stomach medication has been the same for the last month.
Select...
I experience moderate to severe bloating.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Tolerability of the TENS device
Secondary study objectives
Assessment of the Effect of TENS of Gastroparesis Symptoms
Assessment of the Safety of TENS in Treating Scleroderma-related Gastroparesis
Efficacy of TENS in treating Scleroderma-related Gastroparesis

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Scleroderma Patients with Gastroparesis SymptomsExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcutaneous Electrical Nerve Stimulation
2022
N/A
~820

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,862 Previous Clinical Trials
6,441,451 Total Patients Enrolled
~11 spots leftby Feb 2026
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