Exploring how electrical stimulation affects constipation in systemic sclerosis patients
Interrogating the Pathophysiological Mechanisms of Constipation in Patients With Systemic Sclerosis
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05989763 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients with systemic sclerosis who experience constipation and have slow colonic transit or rectal hyposensitivity.
Not a fit: Patients who predominantly experience diarrhea or have mixed bowel symptoms may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Houston, Texas
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.