Transcutaneous Electrical Acustimulation (TEA) for the Treatment of Non-Erosive Gastroesophageal Reflux Disease (NERD)
NCT07572708 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 204
Last updated 2026-05-15
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)
Interventions
- DEVICE
-
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.
Sponsors & Collaborators
-
Ningbo Medical Center Lihuili Hospital
lead OTHER_GOV
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-01
- Primary Completion
- 2028-03-15
- Completion
- 2028-03-31
Countries
- China
Study Locations
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