Transcutaneous Auricular Vagus Nerve Stimulation for the Treatment of Reflux Esophagitis: a Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Transcutaneous Auricular Vagus Nerve Stimulation
- Conditions
- Dry Eye Disease
- Sponsor
- Beijing Tongren Hospital
- Enrollment
- 29
- Locations
- 2
- Primary Endpoint
- OSDI
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
wudong0120
Doctor
Beijing Tongren Hospital
Eligibility Criteria
Inclusion Criteria
- •Age \>=18 and Age \<=
- •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.
Arms & Interventions
taVNS group
taVNS device (Elmmedicare, EC100, Shenzhen, China) was used to apply stimulation for patients. Stimulation parameters comprised an electrical current of 1 mA at a frequency of 20 Hz, with a waveform width of 1 ms. Repurposed off-the-shelf devices were utilized for this purpose, with the stimulator generating single square-wave pulses lasting 1 ms each. Enhancing conductivity was achieved by wiping the ear with tap water. The electrodes were placed on the cymba conchae and concha around the affected ear, which is the region of rich vagus nerve branch distribution. Drug: Hyaluronic acid eye drops Participants in both groups received hyaluronic acid eye drops (HYLO COMOD® eye drops, Ursapharm, Ltd., Germany) with the treatment of 3 times a day.
Intervention: Transcutaneous Auricular Vagus Nerve Stimulation
taVNS group
taVNS device (Elmmedicare, EC100, Shenzhen, China) was used to apply stimulation for patients. Stimulation parameters comprised an electrical current of 1 mA at a frequency of 20 Hz, with a waveform width of 1 ms. Repurposed off-the-shelf devices were utilized for this purpose, with the stimulator generating single square-wave pulses lasting 1 ms each. Enhancing conductivity was achieved by wiping the ear with tap water. The electrodes were placed on the cymba conchae and concha around the affected ear, which is the region of rich vagus nerve branch distribution. Drug: Hyaluronic acid eye drops Participants in both groups received hyaluronic acid eye drops (HYLO COMOD® eye drops, Ursapharm, Ltd., Germany) with the treatment of 3 times a day.
Intervention: Hyaluronic acid eye drops
Control Group
taVNS device were applied using the same stimulator, stimulation parameters and same sessions. However, the electrodes were placed on the antihelix around the affected ear, which is the region of few vagus nerve branch distribution. Drug: Hyaluronic acid eye drops Participants in both groups received hyaluronic acid eye drops (HYLO COMOD® eye drops, Ursapharm, Ltd., Germany) with the treatment of 3 times a day.
Intervention: Transcutaneous Auricular Vagus Nerve Stimulation
Control Group
taVNS device were applied using the same stimulator, stimulation parameters and same sessions. However, the electrodes were placed on the antihelix around the affected ear, which is the region of few vagus nerve branch distribution. Drug: Hyaluronic acid eye drops Participants in both groups received hyaluronic acid eye drops (HYLO COMOD® eye drops, Ursapharm, Ltd., Germany) with the treatment of 3 times a day.
Intervention: Hyaluronic acid eye drops
Outcomes
Primary Outcomes
OSDI
Time Frame: Baseline, month 1, 3, and 6
Ocular Surface Disease Index (OSDI) questionnaire: The OSDI questionnaire is designed to assess the severity of symptoms and the impact of ocular surface diseases, such as dry eye disease, on a patient's quality of life.
Secondary Outcomes
- TBUT(Baseline, month 1, 3, and 6)
- Schirmerl(Baseline, month 1, 3, and 6)
- Corneal fluorescein staining (tCFS)(Baseline, month 1, 3, and 6)
- Meibomian Gland Dysfunction Score(Baseline, month 1, 3, and 6)
- Psychological status(Baseline, month 3, 6 and 12)