Transcutaneous Auricular Vagus Nerve Stimulation Treatment on Reflux Esophagitis

Reflux Esophagitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04673643
• Other study ID #: taVNS-RE-2020
• Status: Completed
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: November 1, 2020

Study information

• Verified date: December 2020
• Source: Beijing Tongren Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: November 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 41 Years to 66 Years

Eligibility

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.

Related Conditions & MeSH terms

• Esophagitis
• Esophagitis, Peptic
• Gastroesophageal Reflux
• Reflux Esophagitis

Intervention

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

Locations

Country	Name	City	State
China	Wu Dong	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tongren Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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