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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NCT05989763

Interrogating the Pathophysiological Mechanisms of Constipation in Patients With Systemic Sclerosis

Recruiting
NAAges 18+InterventionalTreatment
The University of Texas Health Science Center, Houston
~60 participants
Updated 2025-06-26 on ClinicalTrials.gov
What's tested:Transcutaneous Electrical Acustimulation (TEA)Sham-TEA

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in slow colonic transit (SCT)
Measured over baseline, week 4 (visit 2)
Systemic Sclerosis
Constipation
Gastrointestinal Motility Disorder
Autonomic Dysfunction
1 sites across 1 states
Texas1
  • Zsuzsanna H McMahan, MD, MHS (M-PI) · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center, Houston
Zsuzsanna H McMahan, MD, MHS (M-PI)
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Eligibility criteria

Inclusion

Patients with SSc-constipation from Aim 1 of the study
Patients with SCT (\>20% radiopaque marks left in the colon 5 days (120 hours) after swallowing the Sitzmark capsule or patients with RH (defined in Aim 1)
Patients not yet on therapy for constipation or patients who continue to experience constipation while on stable therapy for one month prior to TEA.

Exclusion

Patients with symptoms of both diarrhea and constipation but not predominantly symptoms of constipation.
  • 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