Clinical trial NCT04668534: Effect of Transcutaneous Auricular Vagal Nerve Stimulation on Functional Dyspepsia
Official title: Effect of Transcutaneous Auricular Vagal Nerve Stimulation on Functional Dyspepsia: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Functional Dyspepsia
Keywords: Functional Dyspepsia
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2020-12-16
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Responder rate
timeFrame: 4 weeks
Secondary outcomes:
measure: Functional Dyspepsia Symptom Diary (FDSD)
timeFrame: 4 weeks
measure: Gastrointestinal Symptom Rating Scale (GSRS)
timeFrame: 4 weeks
measure: Adequate relief rate
timeFrame: 4 weeks
measure: Elimination rate of cardinal symptom
timeFrame: 4 weeks
Other outcomes:
measure: Short Form of Nepean Dyspepsia Index (SF-NDI)
timeFrame: 4 weeks
measure: Hamilton Anxiety and Depression Scale
timeFrame: 4 weeks
measure: Adverse event
timeFrame: 4 weeks
Locations:
city: Lanzhou
country: China
facility: Lanzhou University Second Hospital
state: Gansu
city: Xi'an
country: China
facility: Xijing Hospital of Digestive Diseases
state: Shaanxi
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
Study officials:
References: