Effect of transcutaneous auricular vagus nerve stimulation on functional esophageal diseases and its central regulatory mechanism

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200064646

Enrollment

Unknown

Registered

2022-10-13

Start date

2022-10-01

Completion date

Unknown

Last updated

2023-05-15

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

Conditions

Functional esophageal diseases

Interventions

Therapy Group:Stimulation of the left auricular thyroid region by taVNS

Sham therapy group:taVNS stimulates the left earlobe area

Normal group:Stimulation of the left auricular thyroid region by taVNS

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-65 years. 2. Compliance with diagnostic criteria for functional esophageal disease. 3. Right-handed. 4. PPI and prokinetic drugs could be discontinued in the week before the study.

Exclusion criteria

Exclusion criteria: 1. Severe comorbidities (e. g. uncontrolled hypertension or gastrointestinal bleeding, severe cardiopulmonary encephalopathy, coronary heart disease, etc); 2. Autoimmune diseases affecting gastrointestinal motility, such as scleroderma and dermatomyositis; 3. History of gastrointestinal or esophageal surgery; 4. Cancer of the esophagus, esophageal polyps or ulcers of any grade, hiatal hernia, organic disease of the stomach such as peptic ulcer, gastric tumor; 5. Eosinophilic esophagitis, reflux esophagitis; 6. The presence of major esophageal motility disorders; 7. Take acid-suppressive drugs, drugs that affect gastrointestinal motility within 1 week before recruitment or fail to quit these drugs; 8. Those who are unable to cooperate with the completion of the corresponding assessment and inspection and withdraw midway; 9. Contraindications for magnetic resonance examination (e. g. having metal dentures or other metal implants that cannot be removed, claustrophobia, etc.).

Design outcomes

Primary

Measure	Time frame
MRI 3D-T1WI structural image;Diffusion tensor imaging, DTI;Resting-state fMRI;Magnetic resonance spectroscopy, MRS;Reflux Disease Questionnaire (RDQ);Northwestern Esophageal Quality of Life Scale (NEQOL);Esophageal hypervigilance and anxiety scale (EHAS);Hamilton Depression Scale, HAMD;Hamilton Anxiety Scale, HAMA;Patient Health Questionnaire-9 (PHQ-9);GAD-7 (General Anxiety Disorder-7);Pittsburgh Sleep Quality Index, PSQI;Arterial spin labeling, ASL;High-resolution manometry, HRM;	—

Measure

Time frame

MRI 3D-T1WI structural image;Diffusion tensor imaging, DTI;Resting-state fMRI;Magnetic resonance spectroscopy, MRS;Reflux Disease Questionnaire (RDQ);Northwestern Esophageal Quality of Life Scale (NEQOL);Esophageal hypervigilance and anxiety scale (EHAS);Hamilton Depression Scale, HAMD;Hamilton Anxiety Scale, HAMA;Patient Health Questionnaire-9 (PHQ-9);GAD-7 (General Anxiety Disorder-7);Pittsburgh Sleep Quality Index, PSQI;Arterial spin labeling, ASL;High-resolution manometry, HRM;

—

Countries

China

Contacts

Public ContactDemao Deng

The People's Hospital of Guangxi Autonomous Region

demaodeng@163.com+86 13507880885

Outcome results

None listed

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