Interrogating the Pathophysiological Mechanisms of Constipation in Patients With Systemic Sclerosis
TEA in SSc
2 other identifiers
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2023
CompletedFirst Posted
Study publicly available on registry
August 14, 2023
CompletedStudy Start
First participant enrolled
February 17, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 14, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2029
June 26, 2025
June 1, 2025
4.5 years
August 4, 2023
June 21, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Change in slow colonic transit (SCT)
slow colonic transit (SCT) is defined by more than 5 (20%) of Sitz markers retained 5 days after ingestion
baseline, week 4 (visit 2)
Secondary Outcomes (4)
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 autonomic dysfunction as assessed by the COMPASS-31 measures
baseline, week 4 (visit 2)
Change in inflammatory cytokines (IL-6, Tumour Necrosis Factor alpha (TNF-alpha) ),
baseline, week 4 (visit 2)
Study Arms (2)
Transcutaneous Electrical Acustimulation (TEA)
EXPERIMENTALSham-TEA
SHAM COMPARATORInterventions
TEA will then be administrated for 1 hour twice daily for a period of 4 weeks
Sham TEA will then be administrated for 1 hour twice daily for a period of 4 weeks
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patients with symptoms of both diarrhea and constipation but not predominantly symptoms of constipation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zsuzsanna H McMahan, MD, MHS (M-PI)
The University of Texas Health Science Center, Houston
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
August 4, 2023
First Posted
August 14, 2023
Study Start
February 17, 2024
Primary Completion (Estimated)
August 14, 2028
Study Completion (Estimated)
September 1, 2029
Last Updated
June 26, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share