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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Transcutaneous Electrical Acustimulation (TEA)
  • Device: Transcutaneous Electrical Acustimulation (TEA)
    TEA will then be administrated for 1 hour twice daily for a period of 4 weeks
Sham Comparator
Sham-TEA
  • Device: Sham-TEA
    Sham TEA will then be administrated for 1 hour twice daily for a period of 4 weeks

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Zsuzsanna H McMahan, MD, MHS (M-PI)
713-500-6883
Zsuzsanna.H.McMahan@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Zsuzsanna H McMahan, MD, MHS (M-PI)
7135007531
Zsuzsanna.H.McMahan@uth.tmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.