Home Transcutaneous Electrical Acustimulation (TEA)
Key facts
- Where
- Ann Arbor, United StatesSee the site
- Phase
- Phase 2/3
Where in United States
- University of MichiganAnn Arbor, United StatesContact: Colin BurnettTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- University of Michigan
- Trial code
- NCT05519683
- Record updated
- 17 September 2026
- Original description
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.Read full original descriptionShow less
Effects of Home-based TEA for Abdominal Pain in Patients With Irritable Bowel Syndrome (IBS)
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.
Inclusion: 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.
Exclusion: 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.