Interrogating the Pathophysiological Mechanisms of Constipation in Patients With Systemic Sclerosis

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT05989763
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Transcutaneous Electrical Acustimulation (TEA) — DEVICE
    TEA will then be administrated for 1 hour twice daily for a period of 4 weeks
  • Sham-TEA — DEVICE
    Sham TEA will then be administrated for 1 hour twice daily for a period of 4 weeks

Study Details

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.

Key Dates

Start date
Feb 17, 2024
Status verified
Jun 2025
Primary completion
Aug 14, 2028
Completion
Sep 1, 2029

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Transcutaneous Electrical Acustimulation (TEA)
  • Sham Comparator: Sham-TEA

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at HoustonHoustonTexas77030
Zsuzsanna H McMahan, MD, MHS (M-PI)
[email protected]
713-500-6883
Sharvari R Kamat
[email protected]
713-500-6898

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