| NCT ID | NCT06646913 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University of Michigan |
| Condition | Scleroderma |
| Study Type | INTERVENTIONAL |
| Enrollment | 16 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2026-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 16 participants in total. It began in 2024-10-01 with a primary completion date of 2026-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06646913 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Scleroderma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06646913 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06646913 currently recruiting?
Yes, NCT06646913 is actively recruiting participants. Contact the research team at khannad@med.umich.edu for enrollment information.
Where is the NCT06646913 trial being conducted?
This trial is being conducted at Ann Arbor, United States.
Who is sponsoring the NCT06646913 clinical trial?
NCT06646913 is sponsored by University of Michigan. The trial plans to enroll 16 participants.