Transcutaneous Auricular Vagus Nerve Stimulation Treatment on Reflux Esophagitis

Study Overview
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Brief Summary
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Objective: To evaluate the effect of Transcutaneous auricular vagus nerve stimulation for the patients reflux esophagitis. Methods: We accrued 29 patients at Beijing TongRen Hospital Affiliated to Capital Medicine University of. All treatments were self-administered by the patients at home after training at the hospital. Patients completed questionnaires at baseline and after 4 weeks, 8 weeks, 12 weeks and 24 weeks. Endoscopy, reflux diagnostic questionnaire (RDQ), gastrointestinal symptom rating scale (GSRS), and SF-36 were performed to evaluate the therapeutic effects. A difference of P < 0.05 was considered statistically significant.

Official Title
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Transcutaneous Auricular Vagus Nerve Stimulation for the Treatment of Reflux Esophagitis: a Pilot Study

Conditions
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Reflux Esophagitis

Intervention / Treatment
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* Device: Transcutaneous Auricular Vagus Nerve Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >=18 and Age <=70. Clinical diagnosis of reflux diagnostic. Exclusion Criteria: History of cirrhosis, renal impairment, tumors, thyroid disease, diabetes, Crohn's disease, or ulcerative colitis. History of GI or abdominal surgery. Pregnant or lactating women.

Ages Eligible for Study
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Minimum Age: 41 Years
Maximum Age: 66 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Transcutaneous Auricular Vagus Nerve Stimulation
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: taVNS<br>Transcutaneous Auricular Vagus Nerve Stimulation | Device: Transcutaneous Auricular Vagus Nerve Stimulation<br>* to use taVNS to treat Reflux Esophagitis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from Baseline in the reflux diagnostic questionnaire(RDQ) at 12 Weeks | The RDQ was used to assess the subjective reflux symptoms covering a 1-wk recall period. RDQ is categorized into four symptom clusters depicting heartburn, chest pain, acid reflux, and food reflux. The total RDQ scores (eight items) were calculated. Patients with RDQ ≥ 12 points were considered to have a relapse. | Day 0 and postintervention at Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from Baseline in the Gastrointestinal symptom scale(GSRS) rating scale at 12 Weeks | GSRS to measure the subjective gastrointestinal symptoms | Day 0 and postintervention at Week 12 | 
| Mean change from Baseline in the 36-items Short Form(SF-36) at 12 Weeks | SF-36 to measure quality of life | Day 0 and postintervention at Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Reflux esophagitis, Transcutaneous auricular vagus nerve stimulation, Gastroesophageal reflux disease