Studying Constipation in Systemic Sclerosis with Transcutaneous Electrical Acustimulation (TEA)
This study is looking into how Transcutaneous Electrical Acustimulation (TEA) might help with constipation in people who have Systemic Sclerosis (SSc). TEA is a device that delivers electrical pulses through the skin. Researchers want to see if TEA can improve how your colon and rectum work by boosting your autonomic nervous system (which controls automatic body functions). You might be able to join if you have SSc-related constipation, especially if you have slow colonic transit (SCT), and are not currently on constipation therapy or still have constipation while on stable therapy. The main goal is to see if TEA changes how quickly food moves through your colon. This study plans to enroll 60 participants, but its current status is unclear.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It involves two groups: one receiving TEA and another receiving Sham-TEA (a inactive version of the device) for 4 weeks.
- What's involved
- You would receive either TEA or Sham-TEA for 1 hour, twice daily, for a period of 4 weeks. Your slow colonic transit (SCT) will be measured at the beginning and after 4 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your progress will be checked at week 4 after starting the intervention.
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Interrogating the Pathophysiological Mechanisms of Constipation in Patients With Systemic Sclerosis
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Zsuzsanna H McMahan, MD, MHS (M-PI) · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center, Houston
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Change in slow colonic transit (SCT)baseline, week 4 (visit 2)
slow colonic transit (SCT) is defined by more than 5 (20%) of Sitz markers retained 5 days after ingestion