Home Transcutaneous Electrical Acustimulation (TEA) for IBS-C

This study is testing two treatments for Irritable Bowel Syndrome with Constipation (IBS-C): Transcutaneous Electrical Acustimulation (TEA), which uses mild electrical pulses similar to acupuncture, and escitalopram (Lexapro), a medication often used for IBS. Researchers want to see how well TEA and Lexapro reduce abdominal pain compared to a control group. You might be able to join if you are 18 or older, have ongoing IBS-C symptoms, and experience significant abdominal pain. The study will measure success by tracking changes in your daily and weekly abdominal pain levels over 14 weeks. The current status of this study is unclear.

Study design: This is an interventional study with 160 planned participants, divided into four groups to compare TEA, Lexapro, and a sham control. It is a parallel-group study, meaning participants are assigned to one treatment group.
What's involved: Participants will receive home-based treatment for 8 weeks. You will complete daily and weekly surveys to track your abdominal pain.
Compensation: Not stated in the trial record.
Follow-up: Your abdominal pain will be measured daily for 14 weeks and weekly for 14 weeks after the start of the study.

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Home Transcutaneous Electrical Acustimulation (TEA)

Recruiting

PHASE2Ages 18+InterventionalTreatment

University of Michigan

~160 participants

Updated 2025-10-14 on ClinicalTrials.gov

What's tested:TEALexapro

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Change in abdominal pain/discomfort via daily Visual Analog Scale (VAS) survey

Measured over Daily for 14 weeks

+1 more outcome measured

Conditions

Irritable Bowel Syndrome With Constipation

Where it's being run

1 sites across 1 states

Michigan1

Study leadership

Borko Nojkov, MD · PRINCIPAL_INVESTIGATOR · University of Michigan

Who to contact

Colin Burnett

[email protected]

734-647-2806

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

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

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).

What this trial measures

Change in abdominal pain/discomfort via daily Visual Analog Scale (VAS) surveyDaily for 14 weeks
Participants will complete a daily VAS survey to measure daily discomfort. There are four metrics measured in this form, abdominal pain, abdominal bloating, abdominal fullness, and abdominal cramping. These are scored on a line from 0 to 10, with 0 being the lowest (no pain) and 10 being the highest (worst imaginable pain) These scores will be totaled each day and compared from day 0 to day 98, or the end of week 14.
Change in global abdominal painWeekly for 14 weeks
Participants will complete a weekly VAS survey to monitor for change in discomfort for the week prior when compared to prior to starting the study. This contains two questions which ask yes/no questions asking about improvement over the prior week, and one question asking for satisfaction of improvement from 0 to 5, 0 being the lowest (not satisfied) and 5 being the highest (very satisfied). These answers will be compared from week 1 to week 14.

Trialytics