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Interrogating the Pathophysiological Mechanisms of Constipation in Patients With Systemic Sclerosis

NCT05989763 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-06-26

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

    collaborator NIH

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Zsuzsanna H McMahan, MD, MHS (M-PI) · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-17
Primary Completion
2028-08-14
Completion
2029-09-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05989763 on ClinicalTrials.gov