Recruiting

Observational Study

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT05989763

Conditions

Systemic Sclerosis

Constipation

Gastrointestinal Motility Disorder

Autonomic Dysfunction

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Transcutaneous Electrical Acustimulation (TEA)

Sham-TEA

Study Details

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.

Conditions

Systemic Sclerosis

Constipation

Gastrointestinal Motility Disorder

Autonomic Dysfunction

Study ID

NCT05989763

Start date

Feb 17, 2024

Status verified date

Jun, 2025

Completion date

Sep 1, 2029

Anticipated

Primary completion date

Aug 14, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Transcutaneous Electrical Acustimulation (TEA)

sham comparator: Sham-TEA

Interventions

Transcutaneous Electrical Acustimulation (TEA)

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

Sham-TEA

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

Primary outcome measure

  • Change in slow colonic transit (SCT) [ Time Frame: baseline, week 4 (visit 2) ]

Central Contacts and Locations

Central contacts

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

7135007531Zsuzsanna.H.McMahan@uth.tmc.edu

Sharvari R Kamat

713-500-6898Sharvari.R.Kamat@uth.tmc.edu

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

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

713-500-6883Zsuzsanna.H.McMahan@uth.tmc.edu

Sharvari R Kamat

713-500-6898Sharvari.R.Kamat@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Jun 26, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2025-06-26.