TEA for Constipation in Systemic Sclerosis
(TEA in SSc Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop your current medications. However, you can participate if you are not on therapy for constipation or if you have been on stable therapy for constipation for at least one month before starting the trial.
Is transcutaneous electrical acustimulation (TEA) safe for humans?
Research indicates that transcutaneous electrical acustimulation (TEA) and similar treatments like transcutaneous electrical stimulation (TES) are generally safe for humans, as they have been used in studies for conditions like chronic constipation and motion sickness without significant safety concerns.12345
How is the Sham-TEA treatment for constipation in systemic sclerosis different from other treatments?
What data supports the effectiveness of the treatment TEA for Constipation in Systemic Sclerosis?
Who Is on the Research Team?
Zsuzsanna H McMahan, MD, MHS (M-PI)
Principal Investigator
The University of Texas Health Science Center, Houston
Are You a Good Fit for This Trial?
This trial is for patients with systemic sclerosis (SSc) who are experiencing constipation. It's open to those not yet treated for constipation or those still having issues despite stable therapy for a month. Participants should have slow colonic transit or rectal hyposensitivity as defined in the study, but can't join if they have both diarrhea and constipation symptoms.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive transcutaneous electrical acustimulation (TEA) to assess its effects on colonic and anorectal physiology
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Sham-TEA
- Transcutaneous Electrical Acustimulation (TEA)
Find a Clinic Near You
Who Is Running the Clinical Trial?
The University of Texas Health Science Center, Houston
Lead Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator