Effect of Transcutaneous Auricular Vagal Nerve Stimulation on Functional Dyspepsia

Functional Dyspepsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04668534
• Other study ID #: KY20202087-F-1
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: March 28, 2022

Study information

• Verified date: December 2020
• Source: Air Force Military Medical University, China
• Contact: Yanglin Pan, M.D.
• Phone: 13991811225
• Email: yanglinpan[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 28, 2022
• Est. primary completion date: December 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyspepsia
• Functional Dyspepsia

Intervention

Device:
• taVNS 10
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)
• taVNS 25
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)
• Control
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)

Locations

Country	Name	City	State
China	Lanzhou University Second Hospital	Lanzhou	Gansu
China	The Second Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi
China	Xijing Hospital of Digestive Diseases	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Air Force Military Medical University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Short Form of Nepean Dyspepsia Index (SF-NDI)	The SF-NDI consists of 10 questions regarding the effects of dyspepsia symptoms ("stomach problems") on different aspects of life (tension, interference with daily activities, eating/drinking, knowledge/control, and work/study). Each response can be from 1 (not at all affected) to 5 (extremely affected), or 0 (N/A), for a total summed score out of 50.	4 weeks
Other	Hamilton Anxiety and Depression Scale	Anxiety and depression of patients are assessed by using Hamilton Anxiety and Depression Scale.; Hamilton Anxiety Scale consists of 14 items. Each item is scored on a scale from 0 (absent) to 4 (most severe) with a total score range of 0-56.; Hamilton Depression Scale consists of 17 items. Individual items scored on 3 point (0 to 2) or 5 point scale (0 to 4); 0=absent, 4=most severe. Total score: 0 to 52.	4 weeks
Other	Adverse event		4 weeks
Primary	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	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
Secondary	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
Secondary	Adequate relief rate	The proportion of patients who acquire overall symptom relief when compared with baseline	4 weeks
Secondary	Elimination rate of cardinal symptom	The proportion of patients whose cardinal symptom is completely eliminated when compared with baseline.	4 weeks