Actively Recruiting
Interrogating the Pathophysiological Mechanisms of Constipation in Patients With Systemic Sclerosis Using Transcutaneous Electrical Acustimulation
Led by The University of Texas Health Science Center, Houston · Updated on 2025-06-26
60
Participants Needed
1
Research Sites
54 weeks
Total Duration
On this page
Sponsors
T
The University of Texas Health Science Center, Houston
Lead Sponsor
N
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying whether transcutaneous electrical acustimulation (TEA) can change colon and anorectal function related to systemic sclerosis (SSc), a condition that can cause constipation. The study focuses on how TEA may improve nerve system function, slow colonic transit (SCT), rectal hyposensitivity (RH), autonomic dysfunction, and inflammatory pathways in people with SSc-related constipation. Participants will be randomly assigned to receive either TEA or a sham (placebo) version of TEA. Both treatments are applied as a device worn for 1 hour, twice daily, over a 4-week period. The study uses a quadruple masking design to compare these two groups and assess their effects on the condition. During the study, participants will undergo evaluations at the start and after 4 weeks, including tests for colonic transit time, rectal sensitivity, autonomic nervous system function using heart rate variability and questionnaires, and inflammatory markers in the blood. The main measurement is the change in slow colonic transit after 4 weeks. The total participation time includes baseline and week 4 visits.
CONDITIONS
Brief Title
Interrogating the Pathophysiological Mechanisms of Constipation in Patients With Systemic Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with systemic sclerosis-related constipation
- Patients with slow colonic transit (more than 20% radiopaque marks left in the colon after 5 days) or rectal hyposensitivity
- Patients not yet on treatment for constipation or those on stable constipation therapy for at least one month prior to study start
You will not qualify if you...
- Patients who have symptoms of both diarrhea and constipation but do not predominantly have constipation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 4 weeks
Participants receive Transcutaneous Electrical Acustimulation (TEA) or Sham-TEA for 1 hour twice daily for 4 weeks.
2 visits (baseline and week 4, in-person)
Trial Site Locations
Total: 1 location
1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
Z
Zsuzsanna H McMahan, MD, MHS (M-PI)
S
Sharvari R Kamat
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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