Home Transcutaneous Electrical Acustimulation (TEA)

Recruiting now · Phase 2/Phase 3

Conditions studied: Irritable Bowel Syndrome With Constipation

In brief

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.

Key facts

Study ID: NCT05519683
Run by: University of Michigan
People needed: 160
Starts: 2022-11-02
Expected to finish: 2026-09-01
Last updated by the study team: 2025-10-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

Unrelated active disorder which may involve abdominal pain, such as inflammatory bowel disease, diabetes or unstable thyroid disease.
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.
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)
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 hypersensitivity to escitalopram or citalopram including any of the inactive ingredients of these formulations.
Known allergy to adhesive Electrocardiogram (ECG) electrodes.
Known angle-closure glaucoma, bipolar disorder, history of seizures or prior suicide attempt or known suicidal thoughts.
Known QTc prolongation or receiving scheduled therapy with a medication associated with prolongation of QTc (screening to be completed at recruitment as detailed above).

Where it is running

University of Michigan — Ann Arbor, Michigan, United States (enrolling)

Full record on ClinicalTrials.gov

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