Actively Recruiting
Home Transcutaneous Electrical Acustimulation (TEA)
Led by University of Michigan · Updated on 2025-10-14
160
Participants Needed
1
Research Sites
199 weeks
Total Duration
On this page
Sponsors
U
University of Michigan
Lead Sponsor
N
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study will assess the efficacy of two active treatments with TEA and a chemical neuromodulator (escitalopram aka Lexapro) versus a sham comparator or control group on abdominal pain.
CONDITIONS
Official Title
Home Transcutaneous Electrical Acustimulation (TEA)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ongoing and symptomatic Irritable Bowel Syndrome with Constipation (IBS-C)
- Significant worst abdominal pain severity measured by Visual Analog Scale during the Phase-in period
- Symptoms present at least 1 day per week for the past 3 months with onset at least 6 months before diagnosis
- Abdominal pain not adequately relieved at screening and randomization
You will not qualify if you...
- Active disorder causing abdominal pain unrelated to IBS, such as inflammatory bowel disease, diabetes, or unstable thyroid disease
- Pregnancy, plans to become pregnant, or breastfeeding; positive pregnancy test at Visit 1 excludes participation
- Any condition that hinders compliance or completion of the study as judged by the investigator
- History of abdominal surgery except cholecystectomy or appendectomy
- Active use of certain medications including prucalopride, domperidone, alosetron, tegaserod, warfarin, antipsychotics, antidiarrheals, frequent opioid or antispasmodic use, or frequent NSAIDs use
- Ongoing use of SSRIs, SNRIs, or other serotonin-active medications including tricyclic antidepressants; chronic escitalopram users excluded
- Inability to avoid medications like MAO inhibitors, methylene blue, linezolid, pimozide, triptans, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, or St. John's Wort; MAO inhibitors cannot be used within 14 days of starting or stopping escitalopram
- Known hypersensitivity to escitalopram, citalopram, or ECG adhesive electrodes
- Known angle-closure glaucoma, bipolar disorder, history of seizures, prior suicide attempt, or suicidal thoughts
- Known QTc prolongation or scheduled therapy with QTc-prolonging medication at recruitment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
C
Colin Burnett
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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