Interrogating the Pathophysiological Mechanisms of Constipation in Patients With Systemic Sclerosis

Not Applicable

Recruiting

• Conditions: Autonomic Dysfunction; Gastrointestinal Motility Disorder; Systemic Sclerosis; Constipation
• Interventions: Device: Sham-TEA; Device: Transcutaneous Electrical Acustimulation (TEA)

• Registration Number: NCT05989763
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-04
• Study First Submitted QC: 2023-08-04
• Study First Posted: 2023-08-14
• Study Start: 2024-02-17
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-23
• Last Update Posted: 2024-05-28
• Primary Completion: 2028-08-14
• Study Completion: 2029-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham-TEA	Sham-TEA	-
Transcutaneous Electrical Acustimulation (TEA)	Transcutaneous Electrical Acustimulation (TEA)	-

Primary Outcome Measures

Name	Time	Method
Change in slow colonic transit (SCT)	baseline, week 4 (visit 2)	slow colonic transit (SCT) is defined by more than 5 (20%) of Sitz markers retained 5 days after ingestion

Secondary Outcome Measures

Name	Time	Method
Change in rectal hyposensitivity as assessed by the anorectal manometry	baseline, week 4 (visit 2)
Change in autonomic dysfunction as assessed by the Heart rate variability (HRV) measures	baseline, week 4 (visit 2)
Change in inflammatory cytokines (IL-6, Tumour Necrosis Factor alpha (TNF-alpha) ),	baseline, week 4 (visit 2)
Change in autonomic dysfunction as assessed by the COMPASS-31 measures	baseline, week 4 (visit 2)	This is a 31 item questionnaire and scores range from 0-100 a higher score indicating more severe autonomic dysfunction

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States