NCT05519683

Home Transcutaneous Electrical Acustimulation (TEA)

Effects of Home-based TEA for Abdominal Pain in Patients With Irritable Bowel Syndrome (IBS)

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The aim of this study is to investigate the potential of TEA to treat abdominal pain in participants with IBS with constipation (IBS-C). The study also aims to compare the electrical neuromodulation therapy (TEA) with medical neuromodulation therapy (escitalopram) in their ability to treat abdominal pain and improve the autonomic dysfunction in participants with IBS-C. This project will investigate the impact of 3 active treatment interventions vs. a sham control intervention on abdominal pain and other IBS symptoms in participants with IBS-C. This is a parallel-group study in which the participants will be divided into 4 treatment groups designed to investigate the feasibility of TEA using optimized parameters in comparison with medical neuromodulation therapy (escitalopram) and sham-TEA. The treatment will be home-based and last for a period of 8 weeks. To preserve scientific integrity and effective masking, certain details of arms and interventions will be made more precise upon or prior to reporting results

Conditions

• Irritable Bowel Syndrome With Constipation

Interventions

Type	Name	Description
DEVICE	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.
DRUG	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.

Timeline

• Start date: 2022-11-02
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2022-08-29
• Last updated: 2025-10-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study