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NCT04953728 · ClinicalTrials.gov registry record · NA

Optimization of Transcutaneous Electrical Acustimulation (TEA) Modalities for Treatment of IBS-C

A NA study, sponsored by University of Michigan.

Completed
Registry status
NA
Development phase
23
Enrollment target

NCT04953728: Completed NA study, sponsored by University of Michigan.

NCT04953728 is a NA study that has completed, run by University of Michigan. The registered enrollment target is 23 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04953728, a NA study, has completed, sponsored by University of Michigan.

COMPLETED
Registry status
NA
Development phase
23 participants
Enrollment target

Study 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.

Primary Outcome

The barostat device will measure the pressure changes in the rectum during controlled distension, as measured in mmHg. The study participant's maximum tolerance of distention will be compared to tolerance pre and post TEA, as well as comparing each administration to the other modalities and the sham. Higher numbers represent a higher degree of tolerance. Each participant came in for 1 treatment in 1 session on each of 5 separate days. The sequence of treatments each participant received over th

Interventions

  • DEVICE Transcutaneous Electrical Acustimulation (TEA)

Trial Details

FieldValue
Enrollment Target 23 participants
Start Date 2021-07-01
Est. Completion 2022-12-05
Phase NA
University of Michigan

1,327 total trials

What the finished NCT04953728 record still lists

NCT04953728 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 1 intervention - of which Transcutaneous Electrical Acustimulation (TEA) is the first listed.

NCT04953728 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04953728 about?

NCT04953728 is a clinical study titled "Optimization of Transcutaneous Electrical Acustimulation (TEA) Modalities for Treatment of IBS-C". 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 betwe...

What is the current status of trial NCT04953728?

This trial is currently completed. It is a NA study. The enrollment target is 23 participants. The study started on 2021-07-01. Estimated completion is 2022-12-05.

What interventions are being tested in trial NCT04953728?

The interventions under investigation include: Transcutaneous Electrical Acustimulation (TEA) (DEVICE).

Who is sponsoring clinical trial NCT04953728?

This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04953728's enrollment target sits among peer trials

23 1755th of 2000 higher than 245 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04953728, the US trial registry maintained by the National Library of Medicine. NCT04953728 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.