Transcutaneous Electrical Acustimulation (TEA) for the Treatment of Non-Erosive Gastroesophageal Reflux Disease (NERD)

Starting soon · Not applicable · Has a placebo group

Conditions studied: Non-erosive Reflux Disease (NERD)

In brief

This multicenter study aims to evaluate whether Transcutaneous Electrical Acustimulation (TEA) is effective in treating Non-Erosive Gastroesophageal Reflux Disease (NERD). NERD is a common condition where patients experience symptoms like heartburn and regurgitation, but no visible damage can be seen in the esophagus during an endoscopy. TEA is a non-invasive treatment that uses a small device to deliver mild electrical stimulation through the skin on specific acupoints. This study will compare the effects of real TEA treatment with a sham (inactive) control. Participants will be randomly assigned to one of two groups: active TEA treatment or sham stimulation. Neither the participants nor the researchers evaluating the outcomes will know which treatment is being given. The main outcome is the improvement of reflux symptoms after 4 weeks of treatment. The results of this study may provide a new non-drug option for patients suffering from NERD.

Key facts

Study ID

NCT07572708

Run by

Ningbo Medical Center Lihuili Hospital

People needed

204

Starts

2026-05-01

Expected to finish

2028-03-31

Last updated by the study team

2026-05-15

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Ningbo Medical Center Lihuili Hospital — Ningbo, Zhejiang, China

Full record on ClinicalTrials.gov

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