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Interrogating the Pathophysiological Mechanisms of Constipation in Patients With Systemic Sclerosis (TEA in SSc)

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Enrolling

Conditions

Systemic Sclerosis
Constipation
Autonomic Dysfunction
Gastrointestinal Motility Disorder

Treatments

Device: Transcutaneous Electrical Acustimulation (TEA)
Device: Sham-TEA

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05989763
HSC-MS-23-0531
1R01AR081382-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

60 participants in 2 patient groups

Transcutaneous Electrical Acustimulation (TEA)
Experimental group
Treatment:
Device: Transcutaneous Electrical Acustimulation (TEA)
Sham-TEA
Sham Comparator group
Treatment:
Device: Sham-TEA

Trial contacts and locations

1

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Central trial contact

Zsuzsanna H McMahan, MD, MHS (M-PI); Sharvari R Kamat

Data sourced from clinicaltrials.gov

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