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Functional DyspepsiaNCT04668534

Effect of Transcutaneous Auricular Vagal Nerve Stimulation on Functional Dyspepsia

A study testing taVNS 10 and taVNS 25 in people with Functional Dyspepsia, run by Air Force Military Medical University, China at 3 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Functional Dyspepsia
What is being tested?
taVNS 10 and taVNS 25
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
3 sitesChina
Study dates
1 Nov 2020to 28 Mar 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)
Show all 9Show fewer
  • Patients with serious mental disorders or tendency to suicide
  • Pregnancy or lactic women
  • Inability to give informed consent

Trial locations and contacts

3 sites in 1 country.

Yanglin Pan, M.D. contact

13991811225

yanglinpan@hotmail.com

China3 sites, 3 recruiting

  • Lanzhou University Second Hospital

    Lanzhou, Gansu

    Xiaojun Huang, M.D.

    Recruiting

  • Xijing Hospital of Digestive Diseases

    Xi'an, Shaanxi, 710032

    Yanglin Pan, M.D., 13991811225 ext. 86-29-84771536, yanglinpan@hotmail.com

    Recruiting

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi

    Na Liu, M.D.

    Recruiting

Other trials in China

About this study

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

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.

Being tested
taVNS 10, taVNS 25, Control
Keywords
Functional Dyspepsia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • taVNS 10Device

    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 25Device

    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)

  • ControlDevice

    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)

Study groups in NCT04668534
Study groupRoleWhat they receive
Treatment group 1ExperimentalBased 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).
Receives: Device: taVNS 10
Treatment group 2ExperimentalBased 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).
Receives: Device: taVNS 25
Control groupActive comparatorBased 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).
Receives: Device: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 4 weeks

Secondary outcomes (4)

  1. 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.

    Measured: 4 weeks

  2. 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.

    Measured: 4 weeks

  3. Adequate relief rate

    The proportion of patients who acquire overall symptom relief when compared with baseline

    Measured: 4 weeks

  4. Elimination rate of cardinal symptom

    The proportion of patients whose cardinal symptom is completely eliminated when compared with baseline.

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2020
  2. Study start1 Nov 2020
  3. Primary completion28 Dec 2021 (estimated)
  4. Study completion28 Mar 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04668534
Sponsor's protocol ID
KY20202087-F-1
Status last verified
Dec 2020
First submitted
6 Dec 2020
Last updated
16 Dec 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Other researchers can contact PI to get IPD.

Publications

  • 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.

    PubMed 37787432

Questions about this trial

What is this clinical trial studying?

A study testing taVNS 10 and taVNS 25 in people with Functional Dyspepsia, run by Air Force Military Medical University, China at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yanglin Pan, M.D. (13991811225, yanglinpan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Responder rate (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04668534, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2020.

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