Effect of Transcutaneous Auricular Vagal Nerve Stimulation on Functional Dyspepsia

Not Applicable

• Conditions: Functional Dyspepsia
• Interventions: Device: taVNS 25; Device: taVNS 10; Device: Control

• Registration Number: NCT04668534
• Lead Sponsor: Air Force Military Medical University, China

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-01
• Status Verified: 2020-12
• Study First Submitted: 2020-12-06
• Study First Submitted QC: 2020-12-13
• Last Update Submitted: 2020-12-13
• Study First Posted: 2020-12-16
• Last Update Posted: 2020-12-16
• Primary Completion: 2021-12-28
• Study Completion: 2022-03-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. 18-65 years old
2. Patients who met the Rome IV diagnostic criteria of FD
3. Moderate to severe FD (functional dyspepsia symptom diary ≥10)
4. Normal upper endoscopy and abdominal ultrasonography within one year.

Exclusion Criteria

1. Injury or inflammation on the ear

2. Asthma or COPD not under control

3. History of cardiac pacemaker planting or other medical digital devices

4. History of VNS treatment

5. 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)

6. Patients with serious mental disorders or tendency to suicide

7. Pregnancy or lactic women

8. Inability to give informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group 2	taVNS 25	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).
Treatment group 1	taVNS 10	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).
Control group	Control	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).

Primary Outcome Measures

Name	Time	Method
Responder rate	4 weeks	The proportion of patients whose Functional Dyspepsia Symptom Diary Total Symptom Scores were reduced ≥5 after four weeks treatment when compared with baseline.

Secondary Outcome Measures

Name	Time	Method
Gastrointestinal Symptom Rating Scale (GSRS)	4 weeks	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.
Elimination rate of cardinal symptom	4 weeks	The proportion of patients whose cardinal symptom is completely eliminated when compared with baseline.
Functional Dyspepsia Symptom Diary (FDSD)	4 weeks	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.
Adequate relief rate	4 weeks	The proportion of patients who acquire overall symptom relief when compared with baseline

Trial Locations

Locations (3)

The Second Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China

Lanzhou University Second Hospital; 🇨🇳 Lanzhou, Gansu, China

Xijing Hospital of Digestive Diseases; 🇨🇳 Xi'an, Shaanxi, China