Recruiting

Phase 2

Phase 3

TEAHome Transcutaneous Electrical Acustimulation (TEA)

Sponsor:

University of Michigan

Code:

NCT05519683

Conditions

Irritable Bowel Syndrome With Constipation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TEA

Lexapro

Study Details

Brief summary:

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

Irritable Bowel Syndrome With Constipation

Study ID

NCT05519683

Start date

Nov 2, 2022

Status verified date

Aug, 2025

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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 Criteria:

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).

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: TEA at location A

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.

sham comparator: TEA at location B

experimental: TEA at location C

experimental: Escitalopram treatment

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.

Interventions

TEA

The TEA device administers a mild electrical shock through the skin, similar to acupuncture. 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.

Lexapro

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.

Primary outcome measure

Change in abdominal pain/discomfort via daily Visual Analog Scale (VAS) survey [ Time Frame: Daily for 14 weeks ]
Change in global abdominal pain [ Time Frame: Weekly for 14 weeks ]

Central Contacts and Locations

Central contacts

Colin Burnett

734-647-2806 bucolin@med.umich.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Colin Burnett

734-647-2806 bucolin@med.umich.edu

More Information

Sponsor

University of Michigan

Last update posted

Oct 14, 2025

Last verified

Aug, 2025

Keywords

Irritable Bowel Syndrome with Constipation
Constipation
Irritable Bowel Syndrome
Colon, Irritable
Irritable Colon

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan on 2025-10-14.