Effect of Transcutaneous Auricular Vagal Nerve Stimulation on Functional Dyspepsia

NCT04668534 | Unknown DMC

• 1 other identifier: KY20202087-F-1
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 3

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.

Conditions

Functional Dyspepsia

Keywords

Functional Dyspepsia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Functional Dyspepsia Symptom Diary (FDSD)

  4 weeks

• Gastrointestinal Symptom Rating Scale (GSRS)

  4 weeks

• Adequate relief rate

  4 weeks

• Elimination rate of cardinal symptom

  4 weeks

Other Outcomes (3)

• Short Form of Nepean Dyspepsia Index (SF-NDI)

  4 weeks

• Hamilton Anxiety and Depression Scale

  4 weeks

• Adverse event

  4 weeks

Study Arms (3)

Treatment group 1

EXPERIMENTAL

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

Treatment group 2

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

taVNS 10 DEVICE

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)

Treatment group 1

taVNS 25 DEVICE

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)

Treatment group 2

Control DEVICE

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)

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Study Sites (3)

Lanzhou University Second Hospital

Lanzhou, Gansu, China

RECRUITING

Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, 710032, China

RECRUITING

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

RECRUITING

Related Publications (1)

• Shi X, Zhao L, Luo H, Deng H, Wang X, Ren G, Zhang L, Tao Q, Liang S, Liu N, Huang X, Zhang X, Yang X, Sun J, Qin W, Kang X, Han Y, Pan Y, Fan D. Transcutaneous Auricular Vagal Nerve Stimulation Is Effective for the Treatment of Functional Dyspepsia: A Multicenter, Randomized Controlled Study. Am J Gastroenterol. 2024 Mar 1;119(3):521-531. doi: 10.14309/ajg.0000000000002548. Epub 2023 Oct 3.

  PMID: 37787432 DERIVED

Central Study Contacts

Yanglin Pan, M.D.

CONTACT

13991811225; yanglinpan@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated professor

Study Record Dates

• First Submitted: December 6, 2020
• First Posted: December 16, 2020
• Study Start: November 1, 2020
• Primary Completion: December 28, 2021
• Study Completion: March 28, 2022
• Last Updated: December 16, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)