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Comparative study on the effect of different frequency percutaneous auricular vagus nerve stimulation in the treatment of functional dyspepsia and its

Comparative study on the effect of different frequency percutaneous auricular vagus nerve stimulation in the treatment of functional dyspepsia and its

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300069108
Enrollment
Unknown
Registered
2023-03-07
Start date
2023-03-15
Completion date
Unknown
Last updated
2023-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

functional dyspepsia

Interventions

High frequency stimulation group:transcutaneous vagus nerve stimulation(20HZ)
Low frequency stimulation group:transcutaneous vagus nerve stimulation(4HZ)
Healthy control group:N/A

Sponsors

Guang 'anmen Hospital, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for FD patients: (1) =18 years old, =65 years old; (2) Meeting the diagnostic criteria of Rome?; (3) No organic, systemic or metabolic diseases were found in routine examination (including gastrointestinal endoscopy); (4) no gastrointestinal motion-promoting drugs, such as cisapili and domperidone, were taken within 1 week before treatment; (5) To participate voluntarily and sign the informed consent. Note: Only patients meeting the above 6 conditions could be included in this study. Inclusion criteria for healthy subjects: (1) In good health without any obvious neurological, mental or medical conditions, especially cerebrovascular stroke, vascular dementia, depression or subclinical hypothyroidism; (2) =18 years old, =65 years old (3) no drug abuse; (4) No contraindications for MRI (claustrophobia with metal implants including pacemakers, metal joints, etc.).

Exclusion criteria

Exclusion criteria: Exclusion criteria for FD patients: (1) Refusing to sign the informed consent form; (2) Those who do not meet the Rome IV diagnostic criteria; Hp test is positive; (3) Dyspepsia caused by any serious or malignant disease, such as liver cirrhosis, heart failure or gastrointestinal tumor; (4) Take drugs that may affect dyspepsia recently, such as anti-secretory drugs, anti-acid drugs, anti-inflammatory drugs, non-steroidal anti-inflammatory drugs, etc; (5) Recently taking prokinetic drugs, such as anticholinergic drugs or dopaminergic drugs; (6) Recently taking anti-anxiety and antidepressant drugs, such as fluoxetine and escitalopram; (7) Patients who are not conscious, have a history of mental illness or are suffering from mental illness; (8) Diabetes, malignant tumor and other serious consumptive diseases; (9) Patients with cardiovascular and liver and kidney dysfunction; (10) Have a history of gastrointestinal surgery; (11) Planned pregnancy, pregnant women and nursing patients; (12) People who are allergic to skin contact; (13) Ear nail area with serious skin damage and absence of auricle; (14) Those with contraindications to MRI (implanted metal in the body, including cardiac pacemaker, metal joint, etc., claustrophobia). Note: Those who meet any of the above conditions will be excluded. Exclusion criteria for healthy subjects: (1) History of neurological and psychiatric diseases (2) Family history of neurological and psychiatric diseases; (3) Metal implants in the body (4) claustrophobia (5) Allergic constitution (6) Pregnancy

Design outcomes

Primary

MeasureTime frame
Overall dyspepsia symptom score;Upper abdominal pain score;Hamilton Anxiety Scale;

Secondary

MeasureTime frame
Nipine dyspepsia Quality of Life Index;Hamilton Depression Scale;

Countries

China

Contacts

Public ContactJiliang Fang

Guang 'anmen Hospital, China Academy of Chinese Medical Sciences

Fangmgh@gmail.com13683338202

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026