Using electrical stimulation to treat bloating in scleroderma patients
Transcutaneous Electrical Nerve Stimulation in Scleroderma
This study is testing if a new electrical device can help people with scleroderma who have bloating and stomach issues feel better.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT06646913 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the acceptability of a transcutaneous electrical acustimulation (TEA) device for alleviating symptoms of distension and bloating in individuals diagnosed with scleroderma-related gastroparesis. Participants will use the TEA device for 45 minutes twice daily after meals and will document their symptoms through daily diaries and biweekly questionnaires. The study focuses on individuals with moderate to severe gastrointestinal symptoms related to scleroderma, assessing the potential benefits of this non-invasive intervention.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with a confirmed diagnosis of systemic sclerosis and moderate to severe symptoms of bloating.
Not a fit: Patients with unrelated active abdominal disorders or known contraindications to TEA may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new non-invasive treatment option for managing gastrointestinal symptoms in scleroderma patients.
How similar studies have performed: While this approach is novel in the context of scleroderma, similar studies using electrical stimulation for gastrointestinal issues have shown promise.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Classification of Systemic Sclerosis according to the 2013 American College of Rheumatology and European League against Rheumatism classification criteria. 2. Age \>= 18 years 3. English speaking. 4. Participants who report moderate to severe symptoms of distension/bloating on UCLA Scleroderma Clinical Trials Consortium Gastrointestinal Tract Instrument 2.0 5. Stable GI specific therapy including prokinetics over the last 4 weeks. Exclusion Criteria: 1. Pregnancy, or currently lactating. 2. A history of major abdominal surgery (other than cholecystectomy, appendectomy, or deemed as non-major by the investigators) 3. Unrelated active disorder which may involve abdominal pain, such as inflammatory bowel disease, diabetes or unstable thyroid disease. 4. Known allergy to adhesive ECG electrodes. 5. Known contraindications to TEA (e.g., cardiac pacemaker, epilepsy)
Where this trial is running
Ann Arbor, Michigan
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Study coordinator: Dinesh Khanna, MD, MSc
- Email: khannad@med.umich.edu
- Phone: 734-936-5615
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.