Back to resultsEffect of Transcutaneous Auricular Vagal Nerve Stimulation on Functional Dyspepsia
Primary Purpose
Functional Dyspepsia
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
taVNS 10
taVNS 25
Control
Sponsored by
About this trial
This is an interventional treatment trial for Functional Dyspepsia focused on measuring Functional Dyspepsia
Eligibility Criteria
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
Sites / Locations
- Lanzhou University Second HospitalRecruiting
- Xijing Hospital of Digestive DiseasesRecruiting
- The Second Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Treatment group 1
Treatment group 2
Control group
Arm Description
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).
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).
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).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Adequate relief rate
The proportion of patients who acquire overall symptom relief when compared with baseline
Elimination rate of cardinal symptom
The proportion of patients whose cardinal symptom is completely eliminated when compared with baseline.
Full Information
NCT ID
NCT04668534
First Posted
December 6, 2020
Last Updated
December 13, 2020
Sponsor
Air Force Military Medical University, China
1. Study Identification
Unique Protocol Identification Number
NCT04668534
Brief Title
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
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
December 28, 2021 (Anticipated)
Study Completion Date
March 28, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Air Force Military Medical University, China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Dyspepsia
Keywords
Functional Dyspepsia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment group 1
Arm Type
Experimental
Arm Description
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).
Arm Title
Treatment group 2
Arm Type
Experimental
Arm Description
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).
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
taVNS 10
Intervention Description
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)
Intervention Type
Device
Intervention Name(s)
taVNS 25
Intervention Description
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)
Intervention Type
Device
Intervention Name(s)
Control
Intervention Description
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)
Primary Outcome Measure Information:
Title
Responder rate
Description
The proportion of patients whose Functional Dyspepsia Symptom Diary Total Symptom Scores were reduced ≥5 after four weeks treatment when compared with baseline.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Functional Dyspepsia Symptom Diary (FDSD)
Description
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.
Time Frame
4 weeks
Title
Gastrointestinal Symptom Rating Scale (GSRS)
Description
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.
Time Frame
4 weeks
Title
Adequate relief rate
Description
The proportion of patients who acquire overall symptom relief when compared with baseline
Time Frame
4 weeks
Title
Elimination rate of cardinal symptom
Description
The proportion of patients whose cardinal symptom is completely eliminated when compared with baseline.
Time Frame
4 weeks
Other Pre-specified Outcome Measures:
Title
Short Form of Nepean Dyspepsia Index (SF-NDI)
Description
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.
Time Frame
4 weeks
Title
Hamilton Anxiety and Depression Scale
Description
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.
Time Frame
4 weeks
Title
Adverse event
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanglin Pan, M.D.
Phone
13991811225
Email
yanglinpan@hotmail.com
Facility Information:
Facility Name
Lanzhou University Second Hospital
City
Lanzhou
State/Province
Gansu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaojun Huang, M.D.
Facility Name
Xijing Hospital of Digestive Diseases
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanglin Pan, M.D.
Phone
13991811225
Ext
86-29-84771536
Email
yanglinpan@hotmail.com
Facility Name
The Second Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Na Liu, M.D.
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Other researchers can contact PI to get IPD.
Learn more about this trial
Effect of Transcutaneous Auricular Vagal Nerve Stimulation on Functional Dyspepsia
We'll reach out to this number within 24 hrs