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

NCT07572708 · tracked via the Priya Life Science China tracker

Sponsor

Ningbo Medical Center Lihuili Hospital

Phase

Not applicable

Started

2026-05-01

Last updated

2026-05-15

Condition(s) studied

Non-erosive Reflux Disease (NERD)

Investigational drug(s) / intervention(s)

Transcutaneous Electrical Acustimulation

Transcutaneous Electrical Acustimulation: Transcutaneous electrical acustimulation delivered via a portable stimulator. Stimulation parameters: 25 Hz pulse frequency, 0.5 ms pulse width, 2 seconds on and 3 seconds off. Current amplitude ranges from 1 to 9.5 mA, adjusted to the maximum level tolerated by the participant. Self-administered at home for 1 hour twice daily (morning and evening, within a flexible time window from 6:00 AM to 9:00 PM) for 4 consecutive weeks.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

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

Primary outcome measure(s)

Title Proportion of 24-Hour Heartburn-Free Days During the 4-Week Treatment Period — Day 1 to Day 28 (the 4-week treatment period)
Description Heartburn is defined as a sensation of warmth, burning, or acid-burning discomfort in the substernal or epigastric region. Heartburn severity is assessed using a 0-3 scale: 0=none; 1=mild (noticed but does not affect activities); 2=moderate (interferes with daily activities); 3=severe (significantly affects daily life or sleep). A heartburn-free day is defined as a day meeting both of the following criteria: heartburn score = 0 on that day, and no use of rescue antacids on that day. The proportion of heartburn-free days is calculated as (number of heartburn-free days) / (number of valid observation days) during the 4-week treatment period.

Trial sites (1)

Facility	City	Region	Status
Ningbo Medical Center Lihuili Hospital	Ningbo	Zhejiang

More Ningbo Medical Center Lihuili Hospital trials in China

A Retrospective Study of Safety and Efficacy of Locoregional Therapies Combined With Anti-VEGF/TKIs and Immune Checkpoint Inhibitors for All Comers of Intention-to-treat Patients With Unresectable Hepatocellular Carcinoma Starting soon

Becotatug Vedotin Plus Anti-PD-1 and S-1 in Patients With EGFR-Positive Advanced Pancreatic Cancer Who Have Failed at Least One Line of Standard Therapy Recruiting

Fecal Microbiota Transplantation for Liver Failure Recruiting

Fruquintinib Combined With Adebrelimab and High and Low Dose Radiotherapy in the Treatment of Second-line and Above Failure MSS Metastatic Colorectal Cancer. Recruiting

Detection of Sepsis Occurrence by Using Blood Fluorescence Recruiting

Other trials for the same condition

Clinical Efficacy Evaluation of Chaizhi Hewei Decoction in the Treatment of Non-Erosive Reflux Disease With Liver-Stomach Disharmony Syndrome Starting soon

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07572708 on ClinicalTrials.gov ↗ ← All trials in China