An interventional study of Transcutaneous Electrical Acustimulation (TEA) and Sham-TEA in Systemic Sclerosis, Constipation and Gastrointestinal Motility Disorder, sponsored by The University of Texas Health Science Center, Houston. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-26.
Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Treatment
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.
688 studies on the registry are indexed under Scleroderma, Systemic; 223 are open to participants now.
This study's planned enrollment of 60 is above the median of 34 across 493 interventional studies indexed under Scleroderma, Systemic.
Browse Scleroderma, Systemic studies →The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
-Patients with symptoms of both diarrhea and constipation but not predominantly symptoms of constipation.
Device: Transcutaneous Electrical Acustimulation (TEA)
Device: Sham-TEA
TEA will then be administrated for 1 hour twice daily for a period of 4 weeks
Sham TEA will then be administrated for 1 hour twice daily for a period of 4 weeks
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
Time frame: baseline, week 4 (visit 2)
Change in rectal hyposensitivity as assessed by the anorectal manometry
Time frame: baseline, week 4 (visit 2)
Change in autonomic dysfunction as assessed by the Heart rate variability (HRV) measures
Time frame: baseline, week 4 (visit 2)
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
Time frame: baseline, week 4 (visit 2)
Change in inflammatory cytokines (IL-6, Tumour Necrosis Factor alpha (TNF-alpha) ),
Time frame: baseline, week 4 (visit 2)
Plan to share: No
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The University of Texas Health Science Center, Houston