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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05989763
Other study ID # HSC-MS-23-0531
Secondary ID 1R01AR081382-01A
Status Recruiting
Phase N/A
First received
Last updated
Start date February 17, 2024
Est. completion date September 1, 2029

Study information

Verified date May 2024
Source The University of Texas Health Science Center, Houston
Contact Zsuzsanna H McMahan, MD, MHS (M-PI)
Phone 7135007531
Email Zsuzsanna.H.McMahan@uth.tmc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date September 1, 2029
Est. primary completion date August 14, 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States The University of Texas Health Science Center at Houston Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in slow colonic transit (SCT) slow colonic transit (SCT) is defined by more than 5 (20%) of Sitz markers retained 5 days after ingestion baseline, week 4 (visit 2)
Secondary Change in rectal hyposensitivity as assessed by the anorectal manometry baseline, week 4 (visit 2)
Secondary Change in autonomic dysfunction as assessed by the Heart rate variability (HRV) measures baseline, week 4 (visit 2)
Secondary Change in autonomic dysfunction as assessed by the COMPASS-31 measures This is a 31 item questionnaire and scores range from 0-100 a higher score indicating more severe autonomic dysfunction baseline, week 4 (visit 2)
Secondary Change in inflammatory cytokines (IL-6, Tumour Necrosis Factor alpha (TNF-alpha) ), baseline, week 4 (visit 2)
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