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NCT04349891 · ClinicalTrials.gov registry record · NA
Transcutaneous Electroacupuncture for Gastrointestinal Motility Disorders
A NA study, sponsored by Johns Hopkins University.
- Terminated
- Registry status
- NA
- Development phase
- 27
- Enrollment target
NCT04349891: Clinical Trial NA study, sponsored by Johns Hopkins University.
NCT04349891 is a NA study that was terminated before completion, run by Johns Hopkins University. The registered enrollment target is 27 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.
The verdict
NCT04349891, a NA study, was terminated before completion, sponsored by Johns Hopkins University.
- TERMINATED
- Registry status
- NA
- Development phase
- 27 participants
- Enrollment target
Study Summary
Gastrointestinal (GI) dysmotility is common in GI motility disorders, such as functional dyspepsia (FD) gastroparesis and chronic constipation. The symptoms of GI dysmotility include abdominal discomfort or pain, early satiety, nausea, vomiting, abdominal distension, bloating, anorexia and reduced bowel movement. . Medical treatment for GI motility disorders is very limited in the US. Acupuncture has frequently been used for treatment of GI ailments in Eastern countries. The most commonly used acupuncture points (acupoints) for focused treatment of GI symptoms are the Neiguan (PC6) and the Zusanli (ST36) points. Electroacupuncture (EA) at PC6 and ST36 has been reported to accelerate gastrointestinal motility in both animals and human. Recently, the investigators have studied the feasibility of transcutaneous electroacupuncture (TEA): electrical stimulation is applied to acupoints via surface electrodes without needles, similar to the commercial available transcutaneous electrical nerve stimulation (TENS) but applied to acupoints. The investigators hypothesize that TEA as a new treatment option, improves GI symptoms in patients with FD, gastroparesis or constipation, improves GI motility and therefore improves quality of life of the patients. The success of this project will lead to a noninvasive and convenient therapy for treating GI motility disorders. The proposed TEA method is expected to improve gastric and colonic functions and thus improve quality of life. In addition, the proposed TEA method and device are self-administrative after training during the first office visit. It provides a long-term treatment option for both FD, gastroparesis and chronic constipation.
Primary Outcome
The effect of TEA on gastrointestinal dysmotility syndrome by changes in the score of the Gastroparesis Cardinal Symptom Index (GCSI) including 9 symptoms: nausea (feeling sick to your stomach as if you were going to vomit or throw up), retching (heaving as if to vomit, but nothing comes up), vomiting, stomach fullness, not able to finish a normal sized meal, feeling excessively full after meals, loss of appetite, bloating (feeling like you need to loose your clothes) and stomach or belly visibl
Interventions
- DEVICE Transcutaneous Electroacupuncture
- DEVICE Sham TEA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2020-10-01 |
| Est. Completion | 2022-07-29 |
| Phase | NA |
Why NCT04349891 stopped before completion
NCT04349891 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 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 2 interventions - of which Transcutaneous Electroacupuncture is the first listed.
NCT04349891 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04349891 about?
NCT04349891 is a clinical study titled "Transcutaneous Electroacupuncture for Gastrointestinal Motility Disorders". Gastrointestinal (GI) dysmotility is common in GI motility disorders, such as functional dyspepsia (FD) gastroparesis and chronic constipation. The symptoms of GI dysmotility include abdominal discomfort or pain, early satiety, nausea, vomiting, abdominal distension, bloating, anorexia and reduced b...
What is the current status of trial NCT04349891?
This trial is currently terminated. It is a NA study. The enrollment target is 27 participants. The study started on 2020-10-01. Estimated completion is 2022-07-29.
What interventions are being tested in trial NCT04349891?
The interventions under investigation include: Transcutaneous Electroacupuncture (DEVICE), Sham TEA (DEVICE).
Who is sponsoring clinical trial NCT04349891?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04349891's enrollment target sits among peer trials
27 1708th of 2000 higher than 291 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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