Testing a device for constipation in people with systemic sclerosis
Tests a device against a sham device for constipation in adults with systemic sclerosis.
Plain-language title generated from the registry record
Registry title: Interrogating the Pathophysiological Mechanisms of Constipation in Patients With Systemic Sclerosis
Key facts
- Where
- Houston, United StatesSee the site
Where in United States
- The University of Texas Health Science Center at HoustonHouston, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The University of Texas Health Science Center, Houston
- Trial code
- NCT05989763
- Record updated
- 26 June 2025
- Original description
The purpose of this study is to determine whether transcutaneous electrical acustimulation (TEA) alters systemic sclerosis (SSc)-related colonic and anorectal physiology by enhancing autonomic nervous system (ANS) function. The study will examine the effects of TEA on slow colonic transit (SCT) and rectal hyposensitivity (RH), to examine whether TEA improves autonomic dysfunction and modulates inflammatory pathways.Read full original descriptionShow less
Interrogating the Pathophysiological Mechanisms of Constipation in Patients With Systemic Sclerosis
The purpose of this study is to determine whether transcutaneous electrical acustimulation (TEA) alters systemic sclerosis (SSc)-related colonic and anorectal physiology by enhancing autonomic nervous system (ANS) function. The study will examine the effects of TEA on slow colonic transit (SCT) and rectal hyposensitivity (RH), to examine whether TEA improves autonomic dysfunction and modulates inflammatory pathways.
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.