NCT06646913Completed
TENS in Scleroderma
Transcutaneous Electrical Nerve Stimulation in Scleroderma
Source: ClinicalTrials.gov · Last updated 13 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 11 (actual)
- First submitted
- 4 Oct 2024
- Start date
- 1 Oct 2024
- Primary completion date
- 2 Jun 2025
- Lead sponsor
- University of Michigan
- Diseases
- Systemic sclerosis (scleroderma)
- NCT number
- NCT06646913
What you commit to
- Study type: Interventional
- Participants enrolled: 11
- From 1 Oct 2024 to the primary completion date, 2 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- A history of major abdominal surgery (other than cholecystectomy, appendectomy, or deemed as non-major by the investigators)
- Unrelated active disorder which may involve abdominal pain, such as inflammatory bowel disease, diabetes or unstable thyroid disease.
- Known allergy to adhesive ECG electrodes.
- Known contraindications to TEA (e.g., cardiac pacemaker, epilepsy)
Other
- Pregnancy, or currently lactating.
Who the study is looking for
- Classification of Systemic Sclerosis according to the 2013 American College of Rheumatology and European League against Rheumatism classification criteria.
- Age \>= 18 years
- English speaking.
- Participants who report moderate to severe symptoms of distension/bloating on UCLA Scleroderma Clinical Trials Consortium Gastrointestinal Tract Instrument 2.0
- Stable GI specific therapy including prokinetics over the last 4 weeks.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.