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Recruiting NCT05989763

Interrogating the Pathophysiological Mechanisms of Constipation in Patients With Systemic Sclerosis

No phase Interventional Systemic Sclerosis Constipation Gastrointestinal Motility Disorder Autonomic Dysfunction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcutaneous Electrical Acustimulation (TEA), Sham-TEA.
Who it may be relevant to
Registry conditions: Systemic Sclerosis, Constipation, Gastrointestinal Motility Disorder, Autonomic Dysfunction. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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

Primary outcome measures

  • Change in slow colonic transit (SCT) [Time frame: baseline, week 4 (visit 2)]
Secondary outcome measures (4)
  • Change in rectal hyposensitivity as assessed by the anorectal manometry [Time frame: baseline, week 4 (visit 2)]
  • Change in autonomic dysfunction as assessed by the Heart rate variability (HRV) measures [Time frame: baseline, week 4 (visit 2)]
  • Change in autonomic dysfunction as assessed by the COMPASS-31 measures [Time frame: baseline, week 4 (visit 2)]
  • Change in inflammatory cytokines (IL-6, Tumour Necrosis Factor alpha (TNF-alpha) ), [Time frame: baseline, week 4 (visit 2)]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

-Patients with symptoms of both diarrhea and constipation but not predominantly symptoms of constipation.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • The University of Texas Health Science Center at Houston — Houston

Identifiers

NCT: NCT05989763 · HSC-MS-23-0531 · 1R01AR081382-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗