Shock therapy for heartburn? new trial tests TEA device on NERD patients
NCT ID NCT07572708
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a small, non-invasive device that delivers mild electrical pulses to the skin can reduce heartburn in people with Non-Erosive Reflux Disease (NERD). 204 participants will be randomly assigned to receive either real stimulation or a sham (inactive) treatment for 4 weeks. The main goal is to see if the real device increases the number of heartburn-free days.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Transcutaneous electrical acustimulation (TEA) device
- What this could lead to
- If it works, this could provide a new non-drug option for people with NERD to reduce heartburn symptoms.
- What could go wrong
- This is an early-stage trial with no phase designation, and the sham control may show similar effects. The treatment requires daily use for 4 weeks, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 204 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
May 2026
An estimate. Start dates often move.
- Expected to finish
-
Mar 2028
An estimate. End dates often move.
- Lead sponsor
-
A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 18-75 years, irrespective of gender * Typical heartburn symptoms for at least 3 months * Heartburn on at least 2 days during the run-in diary period * Endoscopically confirmed NERD (no esophageal erosions, Los Angeles grade N or M) within 12 months * Willingness and ability to comply with all study procedures and to provide written informed consent Exclusion Criteria: * Familiarity with acupuncture points and their functions (e.g., previous acupuncture experience or medical training) * Any esophageal structural or mucosal disease (e.g., Barrett's esophagus, erosive esophagitis LA grade A-D, eosinophilic esophagitis, esophageal stricture, varices, malignancy, or prior chemical/thermal/radiation injury) * Presence of gastric or duodenal ulcers * History of or suspected diagnosis of functional heartburn or functional dyspepsia by Rome IV criteria * Systemic diseases affecting gastrointestinal motility (e.g., systemic sclerosis, dermatomyositis, systemic lupus erythematosus, amyloidosis), uncontrolled diabetes mellitus (fasting glucose ≥11.1 mmol/L or glycated hemoglobin ≥7.0%), severe cardiovascular disease, significant hepatic or renal dysfunction, or severe psychiatric disorders * Inability to discontinue prohibited medications (PPIs, P-CABs, H2RAs, prokinetics, or other GERD-directed therapies) except for protocol-defined rescue medication during the study * Implanted electronic devices (e.g., pacemaker, defibrillator) or other implants susceptible to electrical stimulation * Local skin disease or severe hypersensitivity at stimulation sites * Pregnancy, breastfeeding, or planned pregnancy during the study period * Participation in other interventional clinical trials within the past 3 months
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Non-erosive reflux disease (NERD) are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, 315000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.