Transcutaneous Electrical Acustimulation (TEA) for the Treatment of Non-Erosive Gastroesophageal Reflux Disease (NERD): A Multicenter, Randomized, Sham-Controlled Trial

NCT07572708 | Not Yet Recruiting

• 1 other identifier: KY2026SL117-01
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-erosive Reflux Disease (NERD)

Keywords

NERD; Transcutaneous electrical Acustimulation; Neuromodulation; Multicenter

Outcome Measures

Primary Outcomes (1)

• Title Proportion of 24-Hour Heartburn-Free Days During 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.

  Day 1 to Day 28 (the 4-week treatment period)

Secondary Outcomes (7)

• Weekly Proportion of 24-Hour Heartburn-Free Days During Treatment

  Week 1, Week 2, Week 3, and Week 4 of the treatment period

• Title Change from Baseline in GERD-Q Total Score

  Baseline (Week 0), Week 4 (end of treatment), and Week 8 (end of follow-up)

• Title Change from Baseline in GERD-HRQL Total Score

  Baseline (Week 0), Week 4 (end of treatment), and Week 8 (end of follow-up)

• Rescue Medication Use

  During the 4-week treatment period (Week 0 to Week 4)

• Persistence of Efficacy After TEA Discontinuation

  Last week of follow-up period (Week 8)

Study Arms (2)

ST36 TEA Group

EXPERIMENTAL

Participants receive active transcutaneous electrical acustimulation (TEA) at the ST36 (Zusanli) acupoint unilaterally.

Device: Transcutaneous Electrical Acustimulation

Sham TEA Group

SHAM COMPARATOR

Participants receive sham transcutaneous electrical acustimulation (TEA) with electrodes placed unilaterally at the olecranon and 3-5 cm vertically down from the olecranon.

Device: Transcutaneous Electrical Acustimulation

Interventions

Transcutaneous Electrical Acustimulation DEVICE

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.

ST36 TEA Group; Sham TEA Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age 18-75 years, irrespective of gender 2. Typical heartburn symptoms for at least 3 months 3. Heartburn on at least 2 days during the run-in diary period 4. Endoscopically confirmed NERD (no esophageal erosions, Los Angeles grade N or M) within 12 months 5. 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) 2. 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) 3. Presence of gastric or duodenal ulcers 4. History of or suspected diagnosis of functional heartburn or functional dyspepsia by Rome IV criteria 5. 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 6. Inability to discontinue prohibited medications (PPIs, P-CABs, H2RAs, prokinetics, or other GERD-directed therapies) except for protocol-defined rescue medication during the study 7. Implanted electronic devices (e.g., pacemaker, defibrillator) or other implants susceptible to electrical stimulation 8. Local skin disease or severe hypersensitivity at stimulation sites 9. Pregnancy, breastfeeding, or planned pregnancy during the study period 10. Participation in other interventional clinical trials within the past 3 months

Sponsors & Collaborators

• Ningbo Medical Center Lihuili Hospital: lead

Study Sites (1)

Ningbo Medical Center Lihuili Hospital

Ningbo, Zhejiang, 315000, China

Location

MeSH Terms

Conditions

Non-Erosive Reflux Disease

Condition Hierarchy (Ancestors)

Gastroesophageal Reflux; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Qiaosu Zhao, MD

CONTACT

+86-158-6720-0749; zhaoqiaosu_2@163.com

pengyu Huang, PhD

CONTACT

+86-133-7700-1986

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2026
• First Posted: May 7, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): March 15, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: May 7, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)