Interrogating the Pathophysiological Mechanisms of Constipation in Patients With Systemic Sclerosis

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Texas
The University of Texas Health Science Center at Houston
RECRUITING
Houston
Contact Information
Primary
Zsuzsanna H McMahan, MD, MHS (M-PI)
Zsuzsanna.H.McMahan@uth.tmc.edu
7135007531
Backup
Sharvari R Kamat
Sharvari.R.Kamat@uth.tmc.edu
713-500-6898
Time Frame
Start Date: 2024-02-17
Estimated Completion Date: 2029-09-01
Participants
Target number of participants: 60
Treatments
Experimental: Transcutaneous Electrical Acustimulation (TEA)
Sham_comparator: Sham-TEA
Related Therapeutic Areas
Sponsors
Leads: The University of Texas Health Science Center, Houston
Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

This content was sourced from clinicaltrials.gov