Systemic Sclerosis, Constipation, Gastrointestinal Motility Disorder, Autonomic Dysfunction
Conditions
Brief 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.
Interventions
TEA will then be administrated for 1 hour twice daily for a period of 4 weeks
DEVICESham-TEA
Sham TEA will then be administrated for 1 hour twice daily for a period of 4 weeks
Sponsors
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in slow colonic transit (SCT) | baseline, week 4 (visit 2) | slow colonic transit (SCT) is defined by more than 5 (20%) of Sitz markers retained 5 days after ingestion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in rectal hyposensitivity as assessed by the anorectal manometry | baseline, week 4 (visit 2) | — |
| Change in autonomic dysfunction as assessed by the Heart rate variability (HRV) measures | baseline, week 4 (visit 2) | — |
| Change in autonomic dysfunction as assessed by the COMPASS-31 measures | baseline, week 4 (visit 2) | This is a 31 item questionnaire and scores range from 0-100 a higher score indicating more severe autonomic dysfunction |
| Change in inflammatory cytokines (IL-6, Tumour Necrosis Factor alpha (TNF-alpha) ), | baseline, week 4 (visit 2) | — |
Countries
United States
Contacts
Primary ContactZsuzsanna H McMahan, MD, MHS (M-PI)
Backup ContactSharvari R Kamat
Outcome results
None listed