Effect of Transcutaneous Auricular Vagal Nerve Stimulation on Functional Dyspepsia

Study Overview
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Brief Summary
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Patients with dyspeptic symptoms vary from 10% to 20% globally. Up to 70% of patients with dyspepsia who undergo endoscopy have unremarkable examination and are diagnosed with functional dyspepsia (FD). Given the lack of information related to its pathophysiology, the treatment is largely empirical and of limited efficacy. Previous small study showed therapeutic potential of transcutaneous auricular vagal nerve stimulation (taVNS) for FD. This study aims to investigate whether taVNS can improve the dyspeptic symptoms of patients with FD.

Official Title
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Effect of Transcutaneous Auricular Vagal Nerve Stimulation on Functional Dyspepsia: a Randomized Controlled Trial

Conditions
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Functional Dyspepsia

Intervention / Treatment
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* Device: taVNS 10
* Device: taVNS 25
* Device: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-65 years old Patients who met the Rome IV diagnostic criteria of FD Moderate to severe FD (functional dyspepsia symptom diary ≥10) Normal upper endoscopy and abdominal ultrasonography within one year. Exclusion Criteria: Injury or inflammation on the ear Asthma or COPD not under control History of cardiac pacemaker planting or other medical digital devices History of VNS treatment Patients with local or systemic diseases which may cause dyspeptic symptoms: Known active peptic ulcer, cholecystitis, gallstone, gastrointestinal obstruction, gastroparesis, and etc.; Known acute or chronic injury of liver or kidney; Obvious hematological abnormality, or endocrine and metabolic diseases; Known malignancy; Obvious cardiovascular or cerebrovascular diseases (such as coronary heart disease, arrhythmia, cerebral infarction and etc.; Other conditions which may be associated with dyspeptic symptoms (such as NSAIDs associated dyspepsia) Patients with serious mental disorders or tendency to suicide Pregnancy or lactic women Inability to give informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group 1<br>Based on the infection of Hp or not, patients will receive quadruple therapy (amoxicillin, clarithromycin, pantoprazole, and bismuth) or PPI (pantoprazole) plus taVNS (produced by by Xi'an Bashui Health Technology Co., Ltd) at left tragus. Patients were given taVNS thirty minutes twice a day in the morning and the night for four weeks (duty circle: 30s on periods and 30s off periods; frequency: 10 Hz; current intensity: minimal pain threshold; pulse width: 500 μs). | Device: taVNS 10<br>* Patients were given taVNS (by Xi'an Bashui Health Technology Co., Ltd) thirty minutes twice a day in the morning and the night for four weeks (duty circle: 30s on periods and 30s off periods; frequency: 10 Hz; current intensity: minimal pain threshold; pulse width: 500 μs)<br>|
| Experimental: Treatment group 2<br>Based on the infection of Hp or not, patients will receive quadruple therapy (amoxicillin, clarithromycin, pantoprazole, and bismuth) or PPI (pantoprazole) plus taVNS (produced by by Xi'an Bashui Health Technology Co., Ltd) at left tragus. Patients were given taVNS thirty minutes twice a day in the morning and the night for four weeks (duty circle: 30s on periods and 30s off periods; frequency: 25 Hz; current intensity: minimal pain threshold; pulse width: 500 μs). | Device: taVNS 25<br>* Patients were given taVNS (by Xi'an Bashui Health Technology Co., Ltd) thirty minutes twice a day in the morning and the night for four weeks (duty circle: 30s on periods and 30s off periods; frequency: 25 Hz; current intensity: minimal pain threshold; pulse width: 500 μs)<br>|
| Active Comparator: Control group<br>Based on the infection of Hp or not, patients will receive quadruple therapy (amoxicillin, clarithromycin, pantoprazole, and bismuth) or PPI (pantoprazole) plus taVNS (produced by by Xi'an Bashui Health Technology Co., Ltd) at left earlobe. Patients were given taVNS thirty minutes twice a day in the morning and the night for four weeks (duty circle: 30s on periods and 30s off periods; frequency: 10 Hz; current intensity: minimal pain threshold; pulse width: 500 μs). | Device: Control<br>* Patients were given taVNS (by Xi'an Bashui Health Technology Co., Ltd) thirty minutes twice a day in the morning and the night for four weeks (duty circle: 30s on periods and 30s off periods; frequency: 10 Hz; current intensity: minimal pain threshold; pulse width: 500 μs)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder rate | The proportion of patients whose Functional Dyspepsia Symptom Diary Total Symptom Scores were reduced ≥5 after four weeks treatment when compared with baseline. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Dyspepsia Symptom Diary (FDSD) | The FDSD consists of 5 cardinal items (burning in the stomach, stomach pain, bloating, postprandial fullness, and early satiety) and 3 supplementary items (nausea, burping/belching rating, and burping/belching bother). Each item can be scored from 0 (no) to 10 (worst). Total Symptom Score includes the 5 cardinal items and ranges from 0 to 50. | 4 weeks | 
| Gastrointestinal Symptom Rating Scale (GSRS) | The GSRS contains 15 items. All individual items are scored on a 7-point Likert scale (1 = not at all to 7 = extremely) and are subsequently clustered into five domains (abdominal pain, reflux, indigestion, diarrhea, and constipation); higher scores indicate more severe symptoms. | 4 weeks | 
| Adequate relief rate | The proportion of patients who acquire overall symptom relief when compared with baseline | 4 weeks | 
| Elimination rate of cardinal symptom | The proportion of patients whose cardinal symptom is completely eliminated when compared with baseline. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Functional Dyspepsia