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

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

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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