NCT05989763

Interrogating the Pathophysiological Mechanisms of Constipation in Patients With Systemic Sclerosis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Systemic Sclerosis
• Constipation
• Gastrointestinal Motility Disorder
• Autonomic Dysfunction

Interventions

Type	Name	Description
DEVICE	Transcutaneous Electrical Acustimulation (TEA)	TEA will then be administrated for 1 hour twice daily for a period of 4 weeks
DEVICE	Sham-TEA	Sham TEA will then be administrated for 1 hour twice daily for a period of 4 weeks

Timeline

• Start date: 2024-02-17
• Primary completion: 2028-08-14
• Completion: 2029-09-01
• First posted: 2023-08-14
• Last updated: 2025-06-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study