Actively Recruiting

Phase 2
Phase 3
Age: 18Years +
All Genders
ID05519683

Effects of Home-based Transcutaneous Electrical Acustimulation (TEA) and Escitalopram on Abdominal Pain in Patients With Irritable Bowel Syndrome With Constipation

Led by University of Michigan · Updated on 2025-10-14

160

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Michigan

Lead Sponsor

N

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating the potential of home-based Transcutaneous Electrical Acustimulation (TEA) to treat abdominal pain in people with Irritable Bowel Syndrome with Constipation (IBS-C). This study compares three active TEA treatments with a chemical neuromodulator, escitalopram (Lexapro), and a sham control to see how well these approaches reduce abdominal pain and improve autonomic dysfunction. The trial involves participants experiencing ongoing abdominal pain related to IBS-C and aims to understand how these therapies affect pain and other IBS symptoms. The study has four groups: three receive TEA stimulation at different body locations using a device that delivers mild electrical shocks similar to acupuncture, applied twice daily for 45 minutes over 8 weeks. The fourth group takes escitalopram, a medication commonly used for IBS, at a dose of 10 mg once daily for 8 weeks. The TEA locations are kept confidential until results are reported to maintain scientific integrity. The study is randomized and compares active treatments with a sham control group. Participants will be monitored for 14 weeks, including the 8-week treatment period and follow-up. They will complete daily and weekly surveys to track changes in abdominal pain using visual scales, symptom severity scores, and quality of life questionnaires. Other assessments include anxiety and depression scales, stool diaries recording bowel movements, stool form, bloating, and urgency. Researchers will collect this data regularly to measure treatment effects and safety throughout the study period.

CONDITIONS

Brief Title

Home Transcutaneous Electrical Acustimulation (TEA)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ongoing and symptomatic Irritable Bowel Syndrome with Constipation (IBS-C)
  • Significant mean worst abdominal pain severity on a Visual Analog Scale (VAS) during the Phase-in period
  • Symptoms present at least 1 day per week in the last 3 months with symptom onset at least 6 months before diagnosis
  • Abdominal pain not adequately relieved at screening and randomization
Not Eligible

You will not qualify if you...

  • Active disorders causing abdominal pain unrelated to IBS-C, such as inflammatory bowel disease, diabetes, or unstable thyroid disease
  • Pregnancy, plans to become pregnant, or lactation; positive pregnancy test at first visit excludes participation
  • Conditions that may prevent compliance or study completion
  • History of abdominal surgery except cholecystectomy or appendectomy
  • Current use of certain medications including prucalopride, domperidone, alosetron, tegaserod, warfarin, antipsychotics, antidiarrheals, frequent opioid or antispasmodic use, or frequent NSAID use
  • Ongoing use of SSRIs, SNRIs, tricyclic antidepressants, or other serotonin-active drugs including escitalopram
  • Inability to avoid specific medications like MAO inhibitors, triptans, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, or St. John's Wort within 14 days of starting/stopping escitalopram
  • Known hypersensitivity to escitalopram or citalopram
  • Allergic to adhesive ECG electrodes
  • Known angle-closure glaucoma, bipolar disorder, history of seizures, prior suicide attempt, or suicidal thoughts
  • Known QTc prolongation or use of medications that prolong QTc interval

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 8 weeks

Participants receive home-based treatment with either the TEA device or escitalopram to manage abdominal pain related to IBS-C. TEA involves twice daily 45-minute sessions of electrical stimulation, while escitalopram is taken once daily for 8 weeks.

Regular monitoring visits may occur according to study protocol

Follow-up

Duration - 6 weeks

Participants continue to be monitored for changes in abdominal pain and other IBS symptoms after treatment ends.

Weekly visits for up to 6 weeks after treatment

Trial Site Locations

Total: 1 location

1

University of Michigan

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

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Research Team

C

Colin Burnett

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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Transcutaneous Electrical Acupoint Stimulation Improves the Outcomes of In Vitro Fertilization: A Prospective, Randomized and Controlled Study.

Fan Qu, Fang-Fang Wang, Yan Wu...

https://pubmed.ncbi.nlm.nih.gov/28915981

Ameliorating Effects of Transcutaneous Electrical Acustimulation Combined With Deep Breathing Training on Refractory Gastroesophageal Reflux Disease Mediated via the Autonomic Pathway.

Yue Yu, Ruiling Wei, Zhi Liu...

https://pubmed.ncbi.nlm.nih.gov/31347247