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NCT Number: NCT05989763

Interrogating the Pathophysiological Mechanisms of Constipation in Patients With Systemic Sclerosis

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.

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Key information

Conditions

Systemic Sclerosis Autonomic Dysfunction Autonomic Nervous System Diseases Connective Tissue Diseases Constipation Gastrointestinal Motility Disorder Nervous System Diseases Pathological Conditions, Signs and Symptoms Primary Dysautonomias Scleroderma, Systemic Signs and Symptoms Signs and Symptoms, Digestive Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcutaneous Electrical Acustimulation (TEA)

Device

TEA will then be administrated for 1 hour twice daily for a period of 4 weeks

Sham-TEA

Device

Sham TEA will then be administrated for 1 hour twice daily for a period of 4 weeks

Primary outcomes

  1. Change in slow colonic transit (SCT)

    Time frame: 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 outcomes

  1. Change in rectal hyposensitivity as assessed by the anorectal manometry

    Time frame: baseline, week 4 (visit 2)

  2. Change in autonomic dysfunction as assessed by the Heart rate variability (HRV) measures

    Time frame: baseline, week 4 (visit 2)

  3. Change in autonomic dysfunction as assessed by the COMPASS-31 measures

    Time frame: 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

  4. Change in inflammatory cytokines (IL-6, Tumour Necrosis Factor alpha (TNF-alpha) ),

    Time frame: baseline, week 4 (visit 2)

Study contacts

Contact information is provided by the study sponsor or research team.

Sharvari R Kamat

CONTACT

[email protected]

713-500-6898

Zsuzsanna H McMahan, MD, MHS (M-PI)

CONTACT

[email protected]

7135007531

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

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

Registry information

Acronym: TEA in SSc

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Aug 14, 2023
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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