Exploring how electrical stimulation affects constipation in systemic sclerosis patients
Official title: Interrogating the Pathophysiological Mechanisms of Constipation in Patients With Systemic Sclerosis
Run by The University of Texas Health Science Center, Houston · NCT05989763 · Data updated 2026-11-12
This study is testing whether a new electrical stimulation treatment can help people with systemic sclerosis who have constipation feel better by improving how their digestive system works.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 1 site (Houston, Texas) |
| Status | Recruiting |
| Started | February 17, 2024 |
| Main results expected | August 14, 2028 |
| Study ends | September 1, 2029 |
| Registry record updated | June 26, 2025 |
| Trial ID | NCT05989763 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients with systemic sclerosis who experience constipation and have slow colonic transit or rectal hyposensitivity.
✕Probably not a fit
Patients who predominantly experience diarrhea or have mixed bowel symptoms may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to investigate the effects of transcutaneous electrical acustimulation (TEA) on patients with systemic sclerosis (SSc) who experience constipation. It will assess whether TEA can improve colonic and anorectal function by enhancing autonomic nervous system activity and modulating inflammatory pathways. The study will focus on patients with slow colonic transit and rectal hyposensitivity, comparing the effects of TEA to a sham treatment. The goal is to better understand the pathophysiological mechanisms underlying constipation in these patients.
Why it matters
Potential benefit: If successful, this study could provide a novel treatment option for patients with constipation related to systemic sclerosis.
How similar studies have gone: While the specific approach of using TEA for this condition may be novel, similar studies have shown promise in using electrical stimulation for gastrointestinal motility disorders.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria * 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 Criteria -Patients with symptoms of both diarrhea and constipation but not predominantly symptoms of constipation.
Where it's running
-
The University of Texas Health Science Center at Houston
Houston, Texas, United States Recruiting
Study contacts
- Principal investigator: Zsuzsanna H McMahan, MD, MHS (M-PI) — The University of Texas Health Science Center, Houston
- Study coordinator: Zsuzsanna H McMahan, MD, MHS (M-PI)
- Email: Zsuzsanna.H.McMahan@uth.tmc.edu
- Phone: 7135007531
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.