NCT05989763NARecruiting

Interrogating the Pathophysiological Mechanisms of Constipation in Patients With Systemic Sclerosis

The University of Texas Health Science Center, Houston

Start Date

2/17/2024

Completion Date

9/1/2029

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DEVICE

Transcutaneous Electrical Acustimulation (TEA)

DEVICE

Sham-TEA

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Conditions

Systemic SclerosisConstipationGastrointestinal Motility DisorderAutonomic Dysfunction

Locations

The University of Texas Health Science Center at Houston

Houston, Texas 77030

United States