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Transcutaneous Auricular Vagus Nerve Stimulation Treatment on Reflux Esophagitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04673643
Recruitment Status : Completed
First Posted : December 17, 2020
Last Update Posted : December 22, 2020
Sponsor:
Information provided by (Responsible Party):
wudong0120, Beijing Tongren Hospital

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Reflux Esophagitis Device: Transcutaneous Auricular Vagus Nerve Stimulation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Transcutaneous Auricular Vagus Nerve Stimulation
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transcutaneous Auricular Vagus Nerve Stimulation for the Treatment of Reflux Esophagitis: a Pilot Study
Actual Study Start Date : July 1, 2018
Actual Primary Completion Date : October 1, 2020
Actual Study Completion Date : November 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arms and Interventions
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Arm Intervention/treatment
Experimental: taVNS
Transcutaneous Auricular Vagus Nerve Stimulation
 Device: Transcutaneous Auricular Vagus Nerve Stimulation
to use taVNS to treat Reflux Esophagitis


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   41 Years to 66 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04673643


Locations
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China
Wu Dong
Beijing, China
Sponsors and Collaborators
Beijing Tongren Hospital
Investigators
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Principal Investigator: Haihong Lian, Doc BeijingTongren Hospital, Capital Medical University
More Information
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Responsible Party: wudong0120, Doctor, Beijing Tongren Hospital
ClinicalTrials.gov Identifier: NCT04673643    
Other Study ID Numbers: taVNS-RE-2020
First Posted: December 17, 2020    Key Record Dates
Last Update Posted: December 22, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by wudong0120, Beijing Tongren Hospital:
Reflux esophagitis
Transcutaneous auricular vagus nerve stimulation
Gastroesophageal reflux disease
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophagitis
Esophagitis, Peptic
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
 Digestive System Diseases
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases