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Taking people in United StatesPhase 2/3

Home skin-patch stimulation or escitalopram for belly pain in constipation-type irritable bowel syndrome

Tests home electrical stimulation and Lexapro for abdominal pain in irritable bowel syndrome with constipation.

Key facts

Who runs it
University of Michigan
Where
Ann Arbor, United StatesSee the site
Trial code
Registry title
Home Transcutaneous Electrical Acustimulation (TEA)
Status
Recruiting
Phase
Phase 2/3
People taking part
160 people, planned
Started
2 Nov 2022
Expected to end
Mar 2027
Type of study
Interventional, 4 groupsOne group gets a sham (pretend) treatment, for comparison.
Treatments tested
  • TEA
  • Lexapro
Record updated
17 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with irritable bowel syndrome with constipation (IBS-C) who have ongoing belly pain. It tests a home skin electrical stimulation device (TEA) and the drug escitalopram (Lexapro).

Age
18 Years and older
Sex
All
Disease stage
Ongoing IBS-C with symptoms. Symptoms at least 1 day/week in the last 3 months, starting at least 6 months before diagnosis. Significant worst belly pain on a pain scale during the run-in period.
Earlier treatment
Belly pain is not relieved enough by current care. People taking SSRIs (including escitalopram), SNRIs, tricyclic antidepressants or other serotonin-active drugs cannot join.

Main reasons for not taking part

  • Other active disease that can cause belly pain, such as inflammatory bowel disease, diabetes or unstable thyroid disease
  • Pregnancy, plans to become pregnant, or breastfeeding
  • Past belly surgery, other than gallbladder or appendix removal
  • Use of certain drugs, such as prucalopride, warfarin, antipsychotics, frequent opioids or frequent NSAIDs
  • Glaucoma of the angle-closure type, bipolar disorder, seizures, suicidal thoughts or attempts, or known QTc prolongation (a heart rhythm finding)

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • Those with ongoing and symptomatic Irritable Bowel Syndrome with Constipation (IBS-C)
  • Significant mean worst abdominal pain severity (as defined by the study protocol, which will be shared with results reporting) on a Visual Analog Scale (VAS) pain score during the Phase-in period
  • Symptoms present at least 1 day/week in the last 3 months with symptom onset at least 6 months prior to the diagnosis
  • Abdominal pain is not adequately relieved at the time of screening and the time of randomization

Who cannot take part

  • Active use of prucalopride, domperidone, alosetron, tegaserod, warfarin, antipsychotic (e.g., Seroquel, Risperdal), antidiarrheal, or frequent (>2 days/week) use of opioid or antispasmodic medication. Those who frequently use Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) will also be excluded
  • Ongoing use of Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs), or any other serotonin-active medications, including tricyclic antidepressants (TCAs). Individuals on chronic SSRI therapy, including escitalopram, at the initial evaluation will not be enrolled in the study
  • Inability to avoid the following medications: tricyclic antidepressants, Monoamine Oxidase (MAO) inhibitors including, intravenous methylene blue, linezolid, and pimozide, as well as triptans, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John's Wort. - - Participants will be informed that MAO inhibitors cannot be used within 14 days of starting or stopping escitalopram
  • Known angle-closure glaucoma, bipolar disorder, history of seizures or prior suicide attempt or known suicidal thoughts
  • Unrelated active disorder which may involve abdominal pain, such as inflammatory bowel disease, diabetes or unstable thyroid disease
  • Any other condition, which in the opinion of the investigator would impede compliance or hinder the completion of the study
  • A history of abdominal surgery (other than cholecystectomy or appendectomy)
  • Known hypersensitivity to escitalopram or citalopram including any of the inactive ingredients of these formulations
  • Known allergy to adhesive Electrocardiogram (ECG) electrodes
  • Known QTc prolongation or receiving scheduled therapy with a medication associated with prolongation of QTc (screening to be completed at recruitment as detailed above)
  • Pregnancy, plans to become pregnant, or lactation. Any potential patient of child-bearing potential will complete a pregnancy test at Visit 1 and if the test is positive that individual will be excluded from future participation

Where in United States

  • University of MichiganAnn Arbor, United StatesContact: Colin BurnettTaking people

About the trial

What the trial wants to find out

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.

The 4 groups in the trial

  • TEA at location ATreatment being tested

    The TEA device administers a mild electrical shock through the skin, similar to acupuncture. Stimulation will be performed twice daily, morning and evening for 45 minutes for 8 weeks. Location sets are described in the protocol, which will be shared with results reporting but are not provided here to maintain masking and, therefore, to safeguard scientific integrity.

    Treatment: TEA

  • TEA at location BSham treatment, for comparison

    The TEA device administers a mild electrical shock through the skin, similar to acupuncture. Stimulation will be performed twice daily, morning and evening for 45 minutes for 8 weeks. Location sets are described in the protocol, which will be shared with results reporting but are not provided here to maintain masking and, therefore, to safeguard scientific integrity.

    Treatment: TEA

  • TEA at location CTreatment being tested

    The TEA device administers a mild electrical shock through the skin, similar to acupuncture. Stimulation will be performed twice daily, morning and evening for 45 minutes for 8 weeks. Location sets are described in the protocol, which will be shared with results reporting but are not provided here to maintain masking and, therefore, to safeguard scientific integrity.

    Treatment: TEA

  • Escitalopram treatmentTreatment being tested

    This arm will receive treatment with the chemical neuromodulator escitalopram (Lexapro) at 10 mg once per day for 8 weeks. Lexapro is often used as a standard treatment for IBS.

    Treatment: Lexapro

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Effects of Home-based TEA for Abdominal Pain in Patients With Irritable Bowel Syndrome (IBS)
Plain-language title
Home skin-patch stimulation or escitalopram for belly pain in constipation-type irritable bowel syndromeGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
17 September 2026