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Effect of Transcutaneous Auricular Vagal Nerve Stimulation on Functional Dyspepsia

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ClinicalTrials.gov Identifier: NCT04668534
Recruitment Status : Recruiting
First Posted : December 16, 2020
Last Update Posted : December 16, 2020
Sponsor:
Information provided by (Responsible Party):
Yanglin Pan, Air Force Military Medical University, China

Study Description
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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.

Condition or disease Intervention/treatment Phase
Functional Dyspepsia Device: taVNS 10 Device: taVNS 25 Device: Control Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Transcutaneous Auricular Vagal Nerve Stimulation on Functional Dyspepsia: a Randomized Controlled Trial
Actual Study Start Date : November 1, 2020
Estimated Primary Completion Date : December 28, 2021
Estimated Study Completion Date : March 28, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment group 1
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
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)
Experimental: Treatment group 2
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
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)
Active Comparator: Control group
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
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)


Outcome Measures
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Primary Outcome Measures :
  1. Responder rate [ Time Frame: 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 :
  1. Functional Dyspepsia Symptom Diary (FDSD) [ Time Frame: 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.

  2. Gastrointestinal Symptom Rating Scale (GSRS) [ Time Frame: 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.

  3. Adequate relief rate [ Time Frame: 4 weeks ]
    The proportion of patients who acquire overall symptom relief when compared with baseline

  4. Elimination rate of cardinal symptom [ Time Frame: 4 weeks ]
    The proportion of patients whose cardinal symptom is completely eliminated when compared with baseline.


Other Outcome Measures:
  1. Short Form of Nepean Dyspepsia Index (SF-NDI) [ Time Frame: 4 weeks ]
    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.

  2. Hamilton Anxiety and Depression Scale [ Time Frame: 4 weeks ]

    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.


  3. Adverse event [ Time Frame: 4 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04668534


Contacts
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Contact: Yanglin Pan, M.D. 13991811225 yanglinpan@hotmail.com

Locations
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China, Gansu
Lanzhou University Second Hospital Recruiting
Lanzhou, Gansu, China
Contact: Xiaojun Huang, M.D.         
China, Shaanxi
Xijing Hospital of Digestive Diseases Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Yanglin Pan, M.D.    13991811225 ext 86-29-84771536    yanglinpan@hotmail.com   
The Second Affiliated Hospital of Xi'an Jiaotong University Recruiting
Xi'an, Shaanxi, China
Contact: Na Liu, M.D.         
Sponsors and Collaborators
Air Force Military Medical University, China
More Information
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Responsible Party: Yanglin Pan, Associated professor, Air Force Military Medical University, China
ClinicalTrials.gov Identifier: NCT04668534    
Other Study ID Numbers: KY20202087-F-1
First Posted: December 16, 2020    Key Record Dates
Last Update Posted: December 16, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Other researchers can contact PI to get IPD.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yanglin Pan, Air Force Military Medical University, China:
Functional Dyspepsia
Additional relevant MeSH terms:
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Dyspepsia
Signs and Symptoms, Digestive