CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 23 enrolled
Drug / intervention
Transcutaneous Electrical Acustimulation (TEA)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04953728
NCT04953728N/ACompleted

TEA for Study Participants With IBS-C Optimization of TEA Modalities for Treatment of IBS-C: A Phase 1 25 Study Participant Clinical Trial of Transcutaneous Electrical Acustimulation (TEA) in Study Participants With IBS-C

University of Michigan·interventional·Posted Jul 8, 2021·Updated Feb 16, 2024

In Brief

A clinical study evaluating Transcutaneous Electrical Acustimulation (TEA) for IBS and Constipation. Completed, enrolled 23 participants across 1 site.

Detailed Summary

This study aims to determine the most effective treatment with Transcutaneous Electrical Acustimulation (TEA) for Irritable Bowel Syndrome with Constipation (IBS-C) by comparing efficacy between 5 separate sessions. The rectum pressure as measured by a device called a barostat will be compared between visits. Each session will be testing a different combination of frequency and body position of the electrodes. Electrodes placed at either the wrist or knee will be stimulated at either 25 Hz or 100 Hz.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIBS, Constipation
CountriesUnited States

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJul 8, 2021
Enrollment StartJul 1, 2021
Primary CompletionDec 5, 2022
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 5.0 years ago

Interventions

Transcutaneous Electrical Acustimulation (TEA)device

Each participant will undergo 5 sessions total at two different frequencies (25 Hz and 100Hz) with electrodes placed at two different locations (wrist and knee) and a placebo session.