Transcutaneous Auricular Vagus Nerve Stimulation Treatment on Reflux Esophagitis

Overview

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.

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

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Primary Purpose: Treatment
  • Masking: None (Open Label)
• Study Primary Completion Date: October 1, 2020

Interventions

• Device: Transcutaneous Auricular Vagus Nerve Stimulation
  • to use taVNS to treat Reflux Esophagitis

Arms, Groups and Cohorts

• Experimental: taVNS
  • Transcutaneous Auricular Vagus Nerve Stimulation

Clinical Trial Outcome Measures

Primary Measures

• Mean change from Baseline in the reflux diagnostic questionnaire(RDQ) at 12 Weeks
  • Time Frame: Day 0 and postintervention at Week 12
  • 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.

Secondary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

1. Age >=18 and Age <=70. 2. Clinical diagnosis of reflux diagnostic. Exclusion Criteria:

1. History of cirrhosis, renal impairment, tumors, thyroid disease, diabetes, Crohn's disease, or ulcerative colitis. 2. History of GI or abdominal surgery. 3. Pregnant or lactating women.

Gender Eligibility: All

Minimum Age: 41 Years

Maximum Age: 66 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Beijing Tongren Hospital
• Provider of Information About this Clinical Study
  • Principal Investigator: wudong0120, Doctor – Beijing Tongren Hospital
• Overall Official(s)
  • Haihong Lian, Doc, Principal Investigator, BeijingTongren Hospital, Capital Medical University